Basoplex cold capsules, 20 pcs

Upute za korištenje Basoplex cold capsules, 20 pcs

Important notes (compulsory information):

BasoX cold capsules hard capsules. Areas of application: Cold diseases with cough, cold, head and body aches, light fever.

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



LEAFLET: INFORMATION FOR THE USER

Basoplex cold capsules hard capsules, for application in adults and adolescents from 14 years
Active substances: 325.0 mg Paracetamol / 12.5 mg phenylpropanolamine hydrochloride / 10.0 mg dextromethorphanehydrobromide

Read the entire leaflet carefully before you start taking these medicines, 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 days, contact your doctor.

What is in this leaflet

1. What are Basoplex cold capsules and what are they used for?
2. What should you pay attention to cold capsules before taking Basoplex?
3. How are Basoplex to take cold capsules?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep baskex cold capsules?
6. Content of the pack and further information

1. What are basoplex cold capsules and what are they used for?

BasoFlex cold capsules are a combination of painkillers / fever-cut medium (analgesic / antipyretics), Cough Still (antitussivum) and sympathomimeticity. Basoplex cold capsules are used for colds with cough, cold, head and body aches, light fever.

2. What should you pay attention to cold capsules before taking Basoplex?

BasOplex cold capsules may not be taken:

• if they are allergic to one of the active ingredients or one of the other ingredients of this medicine referred to in section 6,
• with well-known genetically conditional glucose-6-phosphate dehydrogenase deficiency (risk of haemolytic anemia, a particular form of anemia),
• at hypertension (hypertension),
• with crisis hypothyroidism with thyroid hormone poisoning (thyrotoxicosis),
• with diabetes mellitus,
• with a special shape of the green star (Engewinkelglaukom),
• for tumors of the adrenal leaflet (phaochromocytoma),
• with benign enlargement of the prostate (prostateadayom) with residual harvesting,
• for heart disease, rhythmism, heavy vascular changes and patients with increased risk of stroke,
• at asthma bronchiale,
• at chronic obstructive respiratory disease (COPD),
• in pneumonia (pneumonia),
• in case of breath (respiratory insufficiency),
• from children under 14 years,
• if you suffer from a severe impairment of liver function,
• in pregnancy and during lactation,
• with simultaneous use of MAO inhibitors (see "Taking Basoplex Cold Capsules together with other medicines").

Warnings and Precautions:
Please talk to your doctor or pharmacist before taking Basoplex cold capsules. BasoFlex cold capsules may only be applied if there is a dose reduction or a prolonged dosage interval, in the presence of:

• Liver function disorders (e.g. by chronic alcohol abuse, liver inflammation)
• Kidney functional disorders
• the Gilbert syndrome (Meulengracht disease) as well
• for people with a body weight under 43 kg.

In coughing with significant mucus formation, suppression of coughing is not desired. Under these circumstances, you should only assume basoplex cold capsules in consultation and instruct a physician. In order to prevent the risk of overdose, you should make sure that other medicines that are applied at the same time do not contain a paracetamol. For prolonged highly dosed, non-intended use of painkillers, headaches may occur, which must not be treated by increased doses of the medicine. In general, the habitual intake of painkillers, especially when combining multiple analgesic active ingredients leads to permanent kidney damage with the risk of renal failure (analgesics nephropathy). When a massive blood pressure increase occurring (possible after short-term intake of the medicinal product), treatment should be stopped immediately and to question a doctor. 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. The settling symptoms sounds within a few days. Until then, you should not take any painkillers. Before re-taking painkillers, you should seek medical advice. You may not use baskex cold capsules without medical or dental counters more long than 5 days or in higher doses. Please note that the active ingredients contained in BasoOplex cold capsules can lead dextromethorphane hydrobromide and phenylpropanolamine hydrochloride in abuse to a mental and physical dependency. If you tend to pharmaceutical abuse or drug dependence, you should carry out the treatment with Basoplex cold capsules under medical control.

Children and adolescents:
Basoplex cold capsules may not be used in children under 14 years.

Taking Basoplex Cold Capsules along with other medicines:
Inform your doctor or pharmacist if you take / apply other medicines, recently taken / applied / applied or intend to take / use other medicines. With simultaneous use of BasoFlex cold capsules and antidepressants of the monoamine oxidase inhibitor type (MAO inhibitors, certain mood-bright agents) or at a distance of less than 14 days for the last intake, a massive increase in blood pressure can occur. With simultaneous use of BasoFlex cold capsules and antidepressants of the SSRI (selective serotonin reuptake inhibit, such as Citalopram, Sertraline, Paroxetine), there may be a massive increase in blood pressure, or a so-called serotonine syndrome with the following symptoms may occur: Neuromuscular overactivity (trembling, stiffness, increased reflex readiness Hyperreflexia, involuntary muscle floors Cloni, Myocloni), autonomous overactivity (Sweating, overheating, accelerated heartbeat, accelerated breathing, advanced pupils) and psychological changes such as excitation states and confusion. Together with halothan, guanethidine or amantadine, ephedrine and blood pressure-enhancing agents, the sympathomimetic effect of basoplex cold capsules may be reinforced. With simultaneous use of medicines leading to a so-called enzyme induction in the liver, such as e.g. Certain sleeping fluids and antiepileptics (, etc. Phenobarbital, phenytoin, carbamazepine and rifampicin as well as potentially liver-damaging substances is particularly caution because the liver-damaging potential of paracetamol may be increased. Through alcohol abuse can be triggered by otherwise harmless doses of Basoplex cold capsules liver damage. With simultaneous use of other drugs with damping effect on the central nervous system (such as sleeping equipment, sedatives, opioids, some antihistamines, etc.), it can lead to mutual activity gain. With simultaneous use of medicines that inhibit the cytochrome P450-2D6 enzyme system of the liver and thus the degradation of dextromethorphane - In particular, amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenon, thioridazine, cimetidine and ritonavir - can lead to an increase in the concentration of dextromethorphan in the blood. With simultaneous administration of medicines that delay the stomach emptying (e.g., Propanthelin) or accelerate (e.g., Metoclopramide) is also delayed or accelerated the effect entry of BasoSlex cold capsules. In combinations with chloramphenicol, the half-life of chloramphenicol can be extended with the risk of increased toxicity. It can lead to an addition of the effect of phenylpropanolamine hydrochloride and simultaneously administered theophyllin preparations (agent against asthma), especially the inner restlessness increases, but also nervousness, hands, hyperactivity, stomach complaints, nausea and vomiting may occur. With a combined use of BasoFlex cold capsules with mucus-soluble coughing means, due to the limited cough reflex, a hazardous secretary can arise. With simultaneous use of paracetamol and zidovudine (AZT), the inclination to reduce white blood cells (neutropenia) is strengthened. BASOPLEX cold capsules should therefore only be used after medical advice simultaneously with Zidovudin. Interactions are possible with medicaments against gout such as SampleCid: With simultaneous intake of SampleCid, the dose of BasoFlex's cold capsules should be reduced as the degradation of Basoplex cold capsules can be slowed down. Cholestyramine reduces the recording of paracetamol.

Impact of taking Basoplex cold capsules on laboratory tests:
The urinary acidity and blood sugar determination can be influenced.




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:
Paracetamol is placent daytime, i. It penetrates the mother cake (placenta) and reaches the unborn child. To assess the safety of phenylpropanolamine hydrochloride and dextromethorphanhydrobromide during pregnancy, only inadequate data exist. Therefore, Basoplex cold capsules in pregnancy must not be used.

Latving:
Paracetamol goes over into breast milk and should therefore not be used during lactation.

For assessing the safety of phenylpropanolamine hydrochloride and dextromethorphanhydrobromide during breast-feeding, only inadequate data exist. Therefore, Basoplex cold capsules may not be used during lactation.

Certificate and Gardenability:
There are no data on the impact of BasoFlex cold capsules for the procurement and gainability.

Driving and ability to operate machines:
This medicine can also change the response assets as well as intended use that the ability to actively participate in the strain traffic or to operate machines is impaired. This applies even more in combination with alcohol.

Paracetamol-containing medicines should not be taken at the upper dose area or for a long time without a medical or dental council.

3. How are Basoplex to take cold capsules?

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: adults and adolescents from 14 years, if necessary, every 4 hours 2 hard capsules, but at most 8 Hard capsules in 24 hours. In adults and adolescents from 14 Years With a body weight below 43 kg, the dose of at most 6 hard capsules should not be exceeded in 24 hours.

Type of application:
Please take the hard capsules as far as a little cold liquid.

Duration of application:
Basoplex cold capsules may be allowed no longer than 5 days and not in a higher dose, unless the doctor is prescribed. Even with persistent fever or reciprocating the symptoms over more than 3 days, the doctor must be consulted.

Liver function disorders and easy restriction of renal function:
In patients with liver or renal impairment and Gilbert syndrome, the dose must be reduced or the dose interval must be extended. If you have a severe interference of the liver function, you may not occupy basoplex cold capsules.

Heavy restriction of renal function:
In heavy renal insufficiency (creatinine clearance < 10 ML / min) must be adhered to a dose interval of at least 8 hours.

Application in children and adolescents:
Basoplex cold capsules must not be under 14 children under 14 Years are applied.

Please talk to your doctor or pharmacist if you have the impression that the effect of basoplex cold capsules is too strong or too weak.

If you take a bigger amount of baseline cold capsules than you should:
In the case of taking excessive doses of BasoFlex cold capsules, the poisoning phenomena are predominantly determined by the main component paracetamol. A poisoning risk due to paracetamol consists in particular in older people, small children, people with liver diseases, chronic alcohol abuse, chronic malnutrition and while taking medicines leading to an enzyme induction. In these cases, overdose can lead to death. As a rule, symptoms occur within 24 hours: nausea, vomiting, loss of appetite, paleness and abdominal pain. Thereafter, there may be improving the subjective residing, but there are slight body pain as an indication of liver damage. An overdose with about 6 g or more paracetamol as a single dose in adults or with 140 mg / kg body weight as a single dose in children leads to liver cell damage, which can lead to coma, even with a fatal outcome. Clinical symptoms of liver damage are usually visible after 2 days and reach a maximum after 4 to 6 days. Although there are no heavy liver damage, acute kidney failure can come with acute damage to the kidney channels (tubulus necrosis). To other, liver-independent symptoms observed after overdose with paracetamol, pay heart irregularities (Myocardanomalies) and pancreatitis (Pancreatitis). In the case of overdose, excitation states, dizziness, respiratory depression (breathing inhibition) Respiration, hallucinations, anxiety feel, awareness, blood pressure drop, blood pressure rise, tachycardia (accelerated heart attack), cardiovascular collapse, elevated muscle tone (Tension of muscles), tremor (tremor) of the hands and ataxia (Disruption of the movements) occur. If there is suspected overdose with Basoplex cold capsules, a doctor is immediately notified. Under certain circumstances, intensive care monitoring with symptom-related therapy may be required.

If you forget to take BASOPLEX cold capsules:
If you forgot to take BasoFlex cold capsules for the intended time, get this as soon as it is possible. The next intake should then be returned to the intended time. Do not take the double amount when you forget the previous taking.

If you stop taking Basoplex cold capsules:
Please do not break the therapy with Basoplex cold capsules without consulting your doctor, if the ingestion on medical prescription took place.

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. The assessment of side effects is based on the following frequency information:

In the frequency information on side effectthe following categories are based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Rarely:

• Liver and bile diseases: increase certain liver enzymes (Transaminases).

Very rare:

• Diseases of the skin and subcutaneous tissue: Very rarely, trap has been reported by heavy skin reactions.
• Diseases of the nervous system: dizziness, hallucinations, with abuse development of a dependency.
• Diseases of kidneys and urinary tract: Complaints in urinary leave.
• Diseases of the blood and lymphatic system: thrombocytopenia (Reduced number of platelets), Leukopenia (reduced number of white blood cells)

Not known:

• Diseases of the blood and lymphatic system: agranulocytosis, tank tops (pronounced reduction of cellular blood components)
• Diseases of the Immune System: Hypersensitivity reactions for the active substance Paracetamol (of simple skin extraction, itching up to swelling on the face, shortness of breath, welding outbreak, nausea, blood pressure drop, anaphylactic shock)
• Metabolism and nutritional disorders, loss of appetite.
• Nervous system diseases: light insomnia, nervousness, hand coil, headache, dizziness
• Heart diseases: palpitations
• Vascular diseases: Blood pressure rise, lack of risk in different body regions such. As the skin and the legs, circulatory disorders (blood pressure drop or blood pressure increase) in repeated application, massive blood pressure increase (possible after short-term taking of the medicinal product)
• Respiratory diseases, the chest room and mediastinum: Cramping of the bronchial muscles (bronchospasm) for pre-loaded or susceptible persons (analgesics asthma).
• Diseases of the gastrointestinal tract: stomach ache, diarrhea, nausea, vomiting, mouth dryer.

Note: At the first sign of a hypersensitivity response, the preparation should be discontinued and contacting a doctor immediately. In the case of an allergic shock reaction, you can call the next accessible doctor to help. In cooperation with alcohol, the side effects can occur.

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 baskex cold capsules?

Keep this medicine inaccessible to children. Do not store over 30 ° C. You may not use this medicine after the expirable date specified on the carton and the blister to "usable to:". The expiry date refers to the last day of the specified month. 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 more information

What BasOplex Cold Capsules include:
The active ingredients are: paracetamol 325.0 mg, pHenylpropanolamine hydrochloride 12.5 mg, dextromethorphanehydrobromide 10.0 mg. The other ingredients are: preliminary strength (Corn starch), Dimeticon 350, gelatine, titanium dioxide (E 171), Purified water, sodium dodecyl sulfate.

Like Basoplex cold capsules look and content of the pack:
White plug-in capsules containing a white powder. Original pack with 20 hard capsules to take.

Pharmaceutic entrepreneur:
Carinopharm GmbH
Bahnhofstr. 18
31008 Elze
Telephone: 0180 2 1234-01 *
Fax: 0180 2 1234-02 *
E-Mail: [email protected]
* 0.06? per call from the German landline; Mobile highlight price: 0.42? per minute.

Manufacturer:
Riemser Pharma GmbH
At the WiK 7
17493 Greifswald - Island Riems Phone +49 30 338427-0 Fax +49 38351 308 email [email protected]

This leaflet was recently revised in April 2015.

Source: Information of the leaflet
Status: 10/2016