Barnidipino Teva 20 mg modified-release hard capsules EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Barnidipine Teva 20 mg modified-release hard capsules EFG
barnidipine hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Barnidipine Teva is and what it is used for
- What you need to know before taking Barnidipine Teva
- How to take Barnidipine Teva
- Possible side effects
- How to store Barnidipine Teva
- Contents of the pack and other information
1. What Barnidipine Teva is and what it is used for
The active substance in Barnidipine Teva belongs to a group of medicines called calcium channel blockers. Barnidipine causes dilation of blood vessels, resulting in a reduction of blood pressure. Barnidipine Teva capsules are manufactured in a "prolonged-release" formulation. This means that the active substance is gradually absorbed into the body and has a longer-lasting effect. For this reason, once-daily dosing is sufficient.
Barnidipine is used for the treatment of high blood pressure.
2. What you need to know before taking Barnidipino Teva
Do not take Barnidipino Teva
- if you are allergic to barnidipine or to any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to dihydropyridines (used to treat high blood pressure)
- if you have liver disease
- if you have severe kidney disease
- if you have any of the following specific heart conditions: untreated heart failure, certain forms of chest pain (unstable angina), or acute heart attack
- if you are taking any of the following medicines: protease inhibitors (medicines used to treat AIDS), ketoconazole or itraconazole (medicines used to treat fungal infections), erythromycin or clarithromycin (antibiotics; see “Other medicines and Barnidipino Teva”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Barnidipino Teva
- if you have kidney disease
- if you have heart disease
Children and adolescents
Barnidipino must not be used in children or adolescents under 18 years of age.
Other medicines and Barnidipino Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This is especially important if you are taking any of the following medicines, which MUST NOT be used together with barnidipine (see “Do not take Barnidipino Teva”):
- protease inhibitors (medicines used to treat AIDS)
- ketoconazole or itraconazole (medicines used to treat fungal infections)
- erythromycin or clarithromycin (antibiotics).
Additionally, inform your doctor if you are taking:
- Other medicines used to treat high blood pressure, as they may cause an additional decrease in blood pressure.
- Cimetidine (a medicine used to treat stomach problems), as it may increase the effect of barnidipine.
- Phenytoin or carbamazepine (medicines used to treat epilepsy) or rifampicin (an antibiotic), as higher doses of barnidipine may be required. If you stop treatment with these medicines, your doctor may reduce your dose of barnidipine.
Taking Barnidipino Teva with food and alcohol
Take special care when drinking alcohol or grapefruit juice, as these may increase the effect of barnidipine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
You must not use this medicine during pregnancy unless clearly necessary.
You must not use this medicine while breastfeeding. Barnidipine may pass into breast milk.
Driving and using machines
There is no information suggesting that this medicine affects the ability to drive or operate machinery. However, since this medicine may cause dizziness/vertigo, you should know how it affects you before driving or operating machinery.
Barnidipino Teva contains sucrose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Barnidipino Teva
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose is 10 mg once daily. Your doctor may increase this dose to 1 capsule of 20 mg once daily or 2 capsules of 10 mg once daily.
If you are an elderly person, you may take the normal dose. Your doctor will likely monitor you closely at the beginning of treatment.
Instructions for use
- Take the capsule once daily, in the morning. It is advisable to associate taking the capsule with a daily routine activity, such as brushing your teeth or having breakfast.
- Swallow the capsule whole, preferably with a glass of water. You may take this medicine before, during, or after meals, according to your preference.
- Even when you do not feel any signs or symptoms of high blood pressure, it is important that you continue taking this medicine every day to obtain the full benefits of blood pressure reduction.
If you take more Barnidipino Teva than you should
If you have accidentally taken a large number of capsules at once, you should consult immediately your doctor or someone should take you to the emergency room. Possible symptoms of overdose include weakness, slowed movements, increased heart rate, drowsiness, confusion, nausea, vomiting, and seizures.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Barnidipino Teva
If you forget to take your dose of barnidipine at the usual time, take it as soon as possible on the same day.
If more than 24 hours have passed, DO NOT take a double dose to make up for the missed doses; continue with your usual once-daily dosing schedule.
If you have any further questions about the use of this medicine or wish to discontinue treatment, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience a severe allergic reaction causing difficulty breathing or dizziness, you must inform your doctor or nurse immediately.
Barnidipine may cause the following:
Very common: affect more than 1 in 10 people
- headache
- facial flushing
- fluid accumulation (edema) in arms and legs
Common: may affect up to 1 in 10 people
- dizziness
- palpitations
Frequency not known: frequency cannot be estimated from the available data
- rapid heartbeat
- blood tests showing changes in liver function
- rash
These adverse effects tend to decrease or disappear during treatment (within one month for fluid accumulation and within two weeks for facial flushing, headache, and palpitations).
The following side effects have been observed with some other medicines belonging to the same class as barnidipine:
- overgrowth of the gums (gingival hyperplasia),
- rarely, chest pain on the left side (precordial pain) or chest pain (angina pectoris) (may affect up to 1 in 1,000 people),
- very rarely, an increase in frequency or severity of angina attacks in patients with pre-existing angina pectoris (may affect up to 1 in 10,000 people)
- heart attack (myocardial infarction) has been observed in isolated cases.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Barnidipine Teva
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the blister and packaging following CAD or EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Barnidipino Teva
- The active substance is barnidipine. Each capsule contains 20 mg of barnidipine hydrochloride, equivalent to 18.6 mg of barnidipine.
- The other ingredients (excipients) are:
Capsule contents: sugar spheres (containing sugar syrup, corn starch and sucrose), carboxymethyl ethylcellulose, polysorbate 80, ethylcellulose, talc.
Capsule shell: titanium dioxide (E171), yellow iron oxide (E172), gelatin.
Printing ink: shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.
Appearance of Barnidipino Teva and contents of the pack
Barnidipino Teva 20 mg modified-release hard capsules EFG are hard gelatin capsules filled with granules, yellow to pale yellow in colour. The capsule cap is yellow with black printing "1000" and the body is yellow with black printing "0020".
Available in perforated and non-perforated blisters containing 28, 30, 56 or 60 capsules.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
Teva Nederland BV
Swensweg 5
Haarlem 2031 GA
The Netherlands
or
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80
Kraków, 31-546
Poland
or
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa, 2600
Bulgaria
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma, S.L.U
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas 28108, Madrid (Spain)
Date of the most recent review of this leaflet: February 2022
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/info/87090
Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/