Temagin Pac Tablets, 20 pcs

Upute za korištenje Temagin Pac Tablets, 20 pcs

Important notes (compulsory information):

Temagin Pac Tablets. Applications: Light up to moderately strong pain, such as: headache, toothache, control pain.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.



Important notes (compulsory information):

Temagin Pac Tablets. Areas of application: For symptomatic treatment of light to moderately strong pain, such as headaches, toothache, regulating pain.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Temagin Pac tablets, for application in adults and adolescents from 12 years
Active ingredients: 250 mg acetylsalicylic acid (ph.eur.), 250 mg paracetamol and 50 mg caffeine

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse after 3 to 4 days, contact your doctor.

What is in this leaflet:

1. What is Temagin Pac and what is it used for?
2. What should you consider before taking Temagin PAC?
3. How is Temagin Pac to take?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Temagin PAC?
6. Content of the pack and more information

1. What is Temagin Pac and what is it used for?

Temagin PAC is a combination of acetylsalicylic acid (non-steroidal anti-phlogistikum / analgesic), paracetamol, an analgesic, fever-lowering medicine (analgesic and antipyretic) and caffeine. Temagin PAC is used to symptomatic treatment of light to moderately strong pain, such as headaches, toothache, regulatory pain. Please note the information for children (see section 2. "What should you consider before taking Temagin PAC?"). If you do not feel better or even worse after 3 to 4 days, contact your doctor.

2. What should you consider before taking Temagin PAC?

Temagin PAC may not be taken:

• if they are allergic to acetylsalicylic acid, paracetamol, caffeine or one of the other ingredients of this medicine mentioned in section 6
• if they have in the past against salicylates or other non-steroidal anti-inflammatory inhibitors (certain means against pain, fever or inflammation) with asthma attacks or otherwise hypersensitive
• in gastrointestinal bleeding or breakthrough (perforation) in the history associated with a previous treatment with non-steroidal antirheumatics / anti-phlogistika (NSAR)
• with existing or past repeatedly encountered stomach or twönterine ulcer (peptic ulcer) or bleeding with at least two different episodes of proven ulcers or bleeding
• in sickly increased bleeding tendency
• at liver and renal failure
• if you suffer from a severe impairment of liver function
• for heavy heart muscle weakness (heavy heart failure)
• if you take 15 mg or more methotrexate per week at the same time
• from children under 12 years
• in the last three months of pregnancy.

Wmemberships and precautions:
Please talk to your doctor or pharmacist before taking Temagin Pac.

Special care when taking Temagin PAC is required:

• for hypersensitivity to other anti-inflammatory inhibitors / anti-rheumatics (certain means against rheumatism or inflammation) or other allergy triggering substances
• if there are allergies (eg with skin reactions, itching, nettle fever) or asthma, hay fever, nasal mucosa thresholds (nasal polyps), chronic respiratory diseases
• with limited liver and renal function
• in hypertension and heart performance weakness (Heart insufficiency)
• before surgery (even with smaller interventions such as pulling a tooth); It can come to increased bleeding tendency. Please inform your doctor or dentist when you take Temagin Pac.

Take Temagin Pac only after consulting your doctor:

• if they are chronically alcoholic
• if you suffer from an impairment of liver function (Lieberitis, Gilbert syndrome)
• for prehanded kidney
• for thyroid overfill
• for cardiac arrhythmias
• for anxiety disorders.

Effects on the gastrointestinal tract:
Simultaneous application of acetylsalicylic acid with other non-steroidal anti-inflammatory inhibitors, including so-called COX inhibitors (cyclooxygenase-2 inhibitors), which are used, et al .. against rheumatic complaints, must be avoided. In older patients, side effects after the application of non-steroid anti-inflammatory anti-inflammation, in particular bleeding in the gastric and intestinal area, which can be life-threatening. Of bleeding, ulcer formation and breakthroughs (Perforations) in the gastrointestinal area, which can lead to death, was reported in connection with the taking of all non-steroidal anti-inflammatory inhibitors. They occurred with or without previous warning symptoms or serious events in the gastrointestinal tract in the history at any time of treatment. The risk of this is increasing with increasing NSAR dose, in patients with ulcers in the prehistory, in particular with the complications of bleeding or breakthrough and in older patients. These patients should start treatment with the lowest available dose. Here, a combination therapy with gastric mucosal protective medicinal products (eg misoprostol or proton pump inhibitors) should be considered. This is also recommended for patients who take other medicines that increase the risk of a disease of the gastrointestinal tract. (See section 2. "What should you consider before taking Temagin PAC?" / "Taking Temagin Pac along with other medicines"). Patients, especially at a higher age, which have a history of side effects on the gastrointestinal tract, should report any unusual symptom in the abdomen, especially at the beginning of the treatment. Caution is required in patients who simultaneously occupy medicines that increase the risk for the formation of ulcers or bleeding, eg. Corticoids, blood clotting drugs, such as warfarin, selective serotonin resumption inhibitors, which are prescribed for the treatment of depressive moods or thrombocyte aggregation inhibitors (see section 2 "What should you consider before taking Temagin PAC?" / "When taking Temagin Pac with other medicines "). The treatment can cancel when bleeding or ulcer formation occur in the gastrointestinal tract.

Other notes:
Side effects can be reduced by applying the lowest effective dose to the shortest time required for symptom control. Temagin Pac is not intended to be applied for a long time or in higher doses without a medical or dental council. If your complaints worse or no improvement occurs after 3 days or at high fever, you must consult a doctor. For prolonged highly dosed, non-intended use of painkillers, headaches may occur, which must not be treated by increased doses of the medicine. At abrupt settling after prolonged high-dose, non-intended use of painkillers, headaches as well as fatigue, muscle pain, nervousness and vegetative symptoms can occur. This settling symptoms sounds within a few days. Until then, the re-acceptance of painkillers should be omitted and the re-taking is not without a medical advice. The habitual intake of painkillers can lead to permanent kidney damage with the risk of renal failure (Analgesics nephropathy) or cardiac function (Heart failure) lead. This risk is particularly large if you combine multiple different painkillers. Acetylsalicylic acid reduces uric acid excretion in low doses. In patients who already tend to smaller uric acid excretion, this may cause a gash. In order to prevent the risk of overdose, it should be ensured that other medicines that are applied at the same time do not contain any paracetamol.

Children and adolescents:
Temagin Pac should not be used in children under 12 years. In addition, Temagin PAC is intended to be applied to medical instructions because of the proportion of acetylsalicylic acid in children and adolescents with feverish diseases only on medical instructions and only if other measures do not work. If these diseases come to long-lasting vomiting, this may be a sign of Reye's syndrome, a very rare, but life-threatening disease that necessarily requires immediate medical treatment.

Taking Temagin Pac together with other medicines:
Inform your doctor or pharmacist if you take / apply other medicines Recently taken / applied or intend to take / use other medicines.

Acetylsalicylic acid:
Acetylsalicyl acid increases the effect (thereby the side effect risk may be increased from:

• blood clinical medicines, e.g. Cumarin, Warfarin, Heparin
• Thrombocyte aggregation inhibitors (agents that inhibit the mishap and clumping of platelets), eg ticlopidine, clopidogrel or non-steroidal anti-phlogistika / analgesics and selective serotonin resumption inhibitors (medicinal products for treatment of depressive moods): the risk of bleeding and formation of ulcers in the stomach -Darmtrakt is increased.
• Glucocorticoids (medicines containing cortisone or cortisone-like substances) or other non-steroidal anti-phlogistika / analgesics (inflammatory and pain-resistant means): the risk of gastrointestinal ulcers and Blutrings is increased.
• Digoxin (means for strengthening heart force)
• AntiDiabetika (blood sugar-lowering medicines): The blood sugar level can sink.
• Methotrexate (means for the treatment of cancer or of certain rheumatic diseases)
• Valproinic acid (medium for the treatment of convulsive accidents).

Acetylsalicylic acid reduces the effect of:

• Diuretics (medium for increased urinary excretion) at dosages of Temagin PAC from 3 g of acetylsalicylic acid (corresponds to 12 tablets) per day and more
• ACE inhibitors (certain blood pressure-lowering agents) at dosages of Temagin PAC from 3 g of acetylsalicylic acid (corresponds to 12 tablets) per day and more
• uric acid-excruciating gaskeal (e.g., Samenecid, Benzbromaron).

Paracetamol:
Interactions are possible with:

• Drugs against gout, such as SampleCid: With simultaneous intake of SampleCid, the dose of Temagin PAC should be reduced as the degradation of Temagin PAC can be slowed down.
• Sleeps, such as phenobarbital, agents against epilepsy, such as phenytoin, carbamazepine, means against tuberculosis (rifampicin), Other possibly the liver-damaging medicines: Under certain circumstances, there may be liver damage while taking Temagin PAC.
• Medicines in HIV infections (Zidovudin): The tendency to reduce white blood cells (neutropenia) is reinforcedt. Temagin Pac should therefore only be taken with Zidovudin simultaneously after medical advice.
• Means against nausea (metoclopramide and domperidone): These can cause acceleration of the recording and the effects of Temagin PAC.
• Means for reducing increased blood veals (cholestyramine): These can reduce the recording and thus the effectiveness of Temagin PAC.
• Drugs that slow down the stomach owl: Simultaneous application can lead to a delayed effect entry of Temagin PAC.

Impact of taking Temagin PAC on laboratory tests:
The intake of paracetamol can influence laboratory tests, such as urinary acidity and blood sugar determination.

Caffeine:
Caffeine strengthens the effect (this may increase the side effect rate) of:

• Substances, such as sympathomimetics (certain circulating means), Thyroxine (certain thyroid means) etc.: The heart rate-enhancing effect is increased.
• Paracetamol and some non-steroidal anti-phlogistics (Certain painkillers): The analgesic effect is increased.
• Theophylline (specific medicament for the treatment of lung diseases): The excretion of this medicine is reduced.
• Substances of the type of ephedrin: The dependency potential of can be increased.

Caffeine reduces the effect of:

• Substances, such as barbiturates (certain sleep means), Antihistamines (certain medicines for allergies) etc.: The sleeping effect is reduced.

The following medicines can influence the effect of Caffeine:

• Oral contraceptives (contraceptives), cimetidine (specific medicine for the treatment of gastric ulcer) and disulfiram (Determined alcohol decomposition agent): The caffein degradation in the liver is reduced,
• Barbiturates (certain sleep means) and smoking accelerate the caffein degradation in the liver.
• GyraseHemmer of the quinolon carboxylic acid type (certain medicines for the treatment of infections): The elimination of caffeine and its degradation product Paraxanthin can be delayed.

Taking Temagin Pac together with alcohol:
During the use of Temagin PAC, you should have no alcohol as possible, as alcohol consumption can increase the risk of occurrence of gastric and intestinal ulcers.

Pregnancy, breastfeeding and procilability:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
Temagin Pac should only be taken after strict bewalving the benefit risk ratio during pregnancy. You should not take Temagin PAC during pregnancy for a long time, in high doses or in combination with other medicines, as the safety of the application for these cases is not occupied. In the first and second pregnancy drags, they are allowed to take Temagin PAC only after consultation with acetylsalicylic acid after consultation with their doctor. In the last three months of pregnancy, they are not allowed to use Temagin PAC because of an increased risk of complications for mother and child.

Latving:
The active ingredients go into breast milk. Since adverse consequences for the infant have not become known so far, a short-term use of the recommended dose for light up to moderately strong pain or slight fever a breakage of breastfeeding is usually not required. The foundation and behavior of the infant can be impaired by caffeine recorded with the breast milk. For prolonged application or taking higher doses, you should desele.

Gearability:
Acetylsalicylic acid belongs to a group of medicines (non-steroidal anti-rheumatics) that can affect the fertility of women. This effect is reversible after discontinuation of the medicine (Umkehrbar).

Driving and ability to operate machines:
There are no special precautions required. Nevertheless, after taking a painkiller is always caution.

Temagin pac contains lactose:
Take therefore Temagin pac only after consulting your doctor if you know that you have an intolerance to some sugars.

3. HOW TEMAGIN PAC TAKE?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: From 43 kg - adolescents 12 years and adults: Single dose of 1 to 2 tablets (250 to 500 mg acetylsalicylic acid, 250 to 500 mg acetaminophen and 50 to 100 mg caffeine), Total daily dose of 8 tablets (corresponding to 2 000 mg acetylsalicylic acid, 2 000 mg paracetamol and 400 mg caffeine). The respective dosage interval depends on the symptoms and the maximum total dental dose. It should not be less than 6 hours.

Type of application:
To take. The tablet can be shared in the same doses. Take the tablets whole with plenty of fluid one (preferably a glass of drinking water).

Duration of application:
Take Temagin pac without medical or dental advice not more than 3 days a. When complaints persist for more than 3 days, a doctor should be consulted.

Special populations:

• Liver dysfunction and mild renal impairment: In patients with liver or renal impairment as well as Gilbert's syndrome has reduced the dose or dose interval be extended.
• Heavy renal insufficiency: in heavy renal insufficiency (Creatinine clearance < 10 ml / min) must be adhered to a dose interval of at least 8 hours.
• Older patients: No special dose adjustment is required.
• Children under 12 years: For an application of Temagin Pac in children under 12 years, there is not enough insight material.

If you take a greater amount of Temagin PAC than you should:
Dizziness and ear sheets can, especially in children and elderly patients, be signs of serious poisoning. As a rule, side effects of a paracetamol overdose occur only when exceeding a maximum daily dose of 60 Mg / kg body weight for children and 4000 mg in adults and adults over 12 years. It can within 24 Hours complaints, such as nausea, vomiting, loss of appetite, pastry and abdominal pain occur. It can also come to heavy liver damage. In an overdose with caffeine, central nervous complaints (e.g., unrest, excitement, trembling) and cardiovascular reactions (e.g., cardiac resources, pain in the heart area) are caused. If there is suspected overdose with Temagin PAC, please contact your doctor immediately. This can decide according to the severity of overdose / poisoning on the measures necessary if necessary.

If you forget to take Temagin PAC:
Do not take the double amount when you forget the previous taking.

If you have further questions about taking this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. Numerous of the following undesirable pharmaceutical effects are dose-dependent and individually different. The enumeration of the following undesirable effects comprises all known side effects under treatment with acetylsalicylic acid, including those under high-dose long-term therapy in rheuma capacity. The frequency information that goes beyond individual cases relate to the short-term application up to daily doses of a maximum of 3 G acetylsalicylic acid (= 12 tablets Temagin PAC). In addition, the side effects observed under treatment with paracetamol and caffeine are performed.

Frequently (can up to 1 of 10 treated):

• Gastrointestinal discomfort, such as heartburn, nausea, vomiting, abdominal pain

Occasionally (can concern up to 1 of 100 treated):

• Hypersensitivity reactions, such as skin reactions

Rarely (can concern up to 1,000 treated):

• Gastrointestinal ulcers, under certain circumstances with bleeding and breakthrough. These side effects occurred in particular in older patients. If there are stronger pain in the upper abdomen, bruising, blood in the chair or a black staining of the chair, so you have to settle Temagin PAC and immediately inform the doctor.
• Gastrointestinal bleeding, which can rarely lead to iron deficiency anemia
• easy increase in certain liver enzymes (Serum transamination)

Rarely (can concern up to 1,000 treated) to very rare ((can concern up to 1 out of 10,000 treated):

• serious bleeding, such as brain bleeding, especially in patients with hypertension and / or simultaneous treatment with anticoagulants (Blood clinical medicinal products), which can be life-threatening in individual cases
• Hypersensitivity reactions, such as seizures of respiratory distress, possibly with blood pressure drop, allergic shock, swelling of face, tongue and larynx (Quincke edema) especially in asthmatics

Very rare (can be up to 1 out of 10,000 treated):

• allergic reactions in the form of simple rash or nettle rash to a shock reaction. In the case of an allergic shock reaction, you can call the nearest doctor to help.
• Respiratory constriction at sensitive persons (AnalgeTika asthma). If you observe the above-mentioned side effects, Temagin PAC should not be taken again. Notify your doctor so that it can decide on the severity and, if applicable, further measures.
• heavy skin reactions, such as rash with redness and blistering (e.g. Erythema Exsudativum Multiforme)
• Increase of liver values
• Changes in the blood count, such as a reduced number of platelets (thrombocytopenia) or a strong reduction of certain white blood cells (agranulocytosis)

Unknown (frequency based on the available data not estimable):

• Tachycardia
• Headache, dizziness, disturbed hearing, thighs (Tinnitus) and mental confusion (may be signs of overdose)
• Bleeding, such as nosebleeds, gum bleeding or skin bleeding with a possible extension of bleeding time. This effect can persist over 4 to 8 days after taking.
• Stomach
• Insomnia and inner restlessness.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep Temagin PAC?

Keep this medicine inaccessible to children. You may not use this medicine according to the expirable date specified on the outer carton and the container according to "usable to" or "to". The expiry date refers to the last day of the specified month. Do not store more than 25 ° C. Store in the original packaging to protect the content from moisture. You are allowed to do this medicdo not use TTEL if you notice the following: discoloration or other changes to the tablets by incorrect storage (e.g., moisture influence, damaged blisters). In case of doubt, ask your pharmacist. Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Temagin Pac contains:
The active ingredients are: acetylsalicylic acid (ph. EUR.), Paracetamol and caffeine. Each tablet contains 250 mg of acetylsalicylic acid (pH. EUR.), 250 mg paracetamol and 50 mg caffeine. The other ingredients are: lactose monohydrate, gelatin, corn starch, high-dispersed silica, stearic acid (pH. EUR.).

Like Temagin Pac looks and content of the pack:
Temagin Pac is a white tablet with one-sided breaker. The tablet can be shared in the same doses. Temagin PAC is available in packs with 10 tablets and 20 tablets. There may not be all pack sizes on the market.

Pharmaceutical entrepreneur and manufacturer:
MIBE GmbH medicine
Munich Straße 15
06796 Brehna
Tel.: 034954 / 247-0
Fax: 034954 / 247-100

This leaflet was last revised in July 2013.

Source: Information of the leaflet
Status: 02/2017