CINNARIZINE tablets 25 mg * 50 SOPHARMA
PACKAGE LEAFLET: INFORMATION FOR THE USER
CINNARIZINE SOPHARMA 25 mg tablets CINNARIZINE SOPHARMA 25 mg tablets
Read all of this leaflet carefully before you start taking this medicine.
This medicine can only be obtained without a doctor’s prescription. However, in order to get the best treatment results, you should carefully follow the instructions for use of the medicinal product.
- Keep this leaflet. You may have to read it again.
- If you need further information or advice, ask your pharmacist.
- You should seek medical attention if your symptoms worsen or do not improve.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cinnarizine Sopharma is and what it is used for
2. Before taking Cinnarizine Sopharma
3. How to take Cinnarizine Sopharma
4. Possible side effects
5. How to store Cinnarizine Sopharma
6. Further information
1. WHAT CINNARIZINE SOPHARMA IS AND WHAT IT IS USED FOR
Cinnarizine is a product of a group of medicines called calcium blockers. It improves cerebral and peripheral microcirculation. Suppresses nystagmus (uncontrollable eye movements) and other manifestations of vestibular disorders, reduces the excitability of the labyrinth. It also exhibits some antihistamine (antiallergic) action.
2. BEFORE TAKING CINNARIZINE SOPHARMA
Do not take Cinnarizine Sopharma
- if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Cinnarizine;
- if you are pregnant or breast-feeding.
Take special care with the use of Cinnarizine Sopharma
- if you suffer from Parkinson’s disease or have had symptoms of extraliramid disorders (shaking, orientation and balance disorders);
- if you have hypotension (low blood pressure);
- if you have stomach disease.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Co-administration of Cinnarizine with alcohol, drugs affecting the central nervous system (CNS-depressants or tricyclic antidepressants – for the treatment of depression) leads to a mutual increase in their effects.
Due to its antihistamine (antiallergic) effects, cinnarizine may lead to false negative results in dermatological hypersensitivity samples. This requires discontinuation of cinnarizine treatment at least 4 days before the tests are performed.
Cinnarizine may cause a false positive reaction to anti-doping control tests in athletes.
Taking Cinnarizine Sopharma with food and beverages
No alcohol should be consumed during treatment with the product.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Due to the lack of well-controlled clinical safety studies in pregnant women, the use of cinnarizine during pregnancy is not recommended.
Due to a lack of data on breast milk transfer, its use during lactation is undesirable. In cases of imperative use, breast-feeding should be discontinued.
Driving and using machines
Cinnarizine Sopharma may cause drowsiness, especially at the beginning of treatment, which requires careful use in drivers and machine operators with an accurate benefit/risk assessment.
Important information about some of the ingredients of Cinnarizine Sopharma
Cinnarizine Sopharma contains lactose as an excipient. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicinal product contains wheat starch. Suitable for people with celiac disease. Patients with wheat allergy (other than celiac disease) should not take this medicine.
3. HOW TO TAKE CINNARIZINE SOPHARMA
Always take Cinnarizine Sopharma exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Vestibular symptoms (dizziness, nausea)
Adults and children over 12 years of age: 1 tablet 3 times a day.
Children from 5 to 12 years: 1/2 tablet 3 times a day.
The recommended doses should not be exceeded.
Prevention of kinetasis (travel sickness)
Adults and children over 12 years of age: 1 tablet two hours before the trip and then every 8 hours 1 tablet during the trip.
Children from 5 to 12 years of age: half the adult dose is taken.
If you take more Cinnarizine Sopharma than you should
With an overdose, blood pressure may decrease, trembling, vomiting, drowsiness may occur.
If you take a dose greater than prescribed, contact your doctor or nearest medical institution.
If you forget to take Cinnarizine Sopharma
If you forget to take a dose, take it as soon as possible. If it’s almost time for your next dose, take it as usual, skipping the dose you forgot. Do not take a double dose to make up for the forgotten one. Continue to take the medicine as prescribed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cinnarizine Sopharma can cause side effects, although not everybody gets them.
Most often possible: drowsiness, gastrointestinal discomfort; less common: hypotension (lowering blood pressure), headache; in older persons taking cinnarizine in higher doses for a long time, extrapyramidal symptoms (trembling, disorientation, disturbance in balance) may occur, including Parkinson’s syndrome (shaking, slowness of movement and increased muscle tone), dry mouth, increased sweating, in rare cases weight gain, hypersensitivity reactions, very rarely cholestatic jaundice.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CINNARIZINE SOPHARMA
Store in the original package, in a dry place protected from light, at a temperature below 25 C.
Keep out of the reach of children.
Do not use Cinnarizine Sopharma after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Cinnarizine Sopharma contains
The active substance is cinnarizine 25 mg per tablet.
The other ingredients are: lactose monohydrate; wheat starch; cellulose, microcrystalline; povidone; silica, colloidal anhydrous; magnesium stearate.
What Cinnarizine Sopharma looks like and contents of the pack
Cinnarizine Sopharma are almost white, round, biconvex tablets with a diameter of 7 mm and odorless.
50 tablets in a blister of solid, orange, transparent PVC/aluminium foil; 1 blister in a cardboard box, together with a leaflet.
Marketing Authorisation Holder and Manufacturer
SOPHARMA AD, Bulgaria