NITRENDIPINE STADA 20 mg TABLETS

2. What you need to know before taking Nitrendipine Stada

Do not take Nitrendipine Stada:

• if you are allergic (hypersensitive) to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have unstable angina or have had an acute myocardial infarction in the last 4 weeks.
• if you are pregnant or breastfeeding.
• if you are being treated with the antibiotic rifampicin.

Warnings and precautions

Consult your doctor before starting to take Nitrendipine Stada:

• if you are over 65 years old.
• if you have liver disease.
• if you are already being treated to lower blood pressure.
• if you have heart problems.
• if you have high blood pressure and severe cerebrovascular disease.
• if you experience side effects at the start of treatment.
• in cases of in vitro fertilization, as nitrendipine may reduce the chances of conception.

In all these circumstances, your doctor may start treatment with a lower dose.

Children and adolescents

Nitrendipine should not be used in children or adolescents under 18 years of age.

Use of Nitrendipine Stada with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Certain medications may interact with nitrendipine; in these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

This is especially important when taking:

• Other medications to lower high blood pressure.
• Muscle relaxants such as pancuronium.
• Antibiotics such as rifampicin, erythromycin, quinupristin, or dalfopristin.
• Cardiac stimulants such as digoxin.
• Antiepileptics such as phenytoin, phenobarbital, carbamazepine, or valproic acid.
• Antiretroviral medications, such as ritonavir.
• Antifungals such as ketoconazole.
• Antidepressants such as fluoxetine or nefazodone. Medications that reduce stomach acid production, such as cimetidine or ranitidine.

Taking Nitrendipine Stada with food and drinks

Do not drink alcoholic beverages at the same time as nitrendipine. Do not drink grapefruit juice during treatment with nitrendipine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Nitrendipine is contraindicated during pregnancy and breastfeeding.

In vitro fertilization:

In isolated cases of in vitro fertilization, calcium antagonists such as nitrendipine have been associated with reversible biochemical changes in sperm heads that may lead to altered sperm function. In men with a history of repeated failure of paternity through in vitro fertilization and in whom no other explanation can be found, calcium antagonists should be considered as a possible reason.

Driving and using machines

Nitrendipine may limit the ability to drive vehicles or operate machinery, especially at the start of treatment.

Nitrendipine Stada contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Nitrendipine Stada

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet once a day (in the morning). If higher doses are needed, your doctor will prescribe a gradual increase in the dose up to two tablets a day (one tablet with breakfast and one with dinner).

Generally, the tablet is taken without chewing with a little liquid (not grapefruit juice) after eating.

Remember to take your medication.

Your doctor will indicate the duration of treatment with nitrendipine, as well as the dose to start with and how to increase it. Do not stop treatment before consulting your doctor. If you need to stop treatment, it is recommended to gradually decrease the dose. Try to take the medication at the same time every day.

Use in patients with liver impairment

In patients with liver problems, the usual starting dose is 10 mg of nitrendipine (half a Nitrendipine Stada tablet).

If you take more Nitrendipine Stada than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicology Information Service. Phone: 91 562 04 20.

The main symptoms of overdose are skin rashes, headache, low blood pressure, and heart problems.

If you forget to take Nitrendipine Stada

Do not take a double dose to make up for forgotten doses. Take it as soon as possible and continue taking it according to your usual schedule.

If you stop taking Nitrendipine Stada

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people):

• Anxiety.
• Headache.
• Palpitations.
• Edema (swelling), vasodilation.
• Flatulence.
• Discomfort.

Uncommon side effects (may affect up to 1 in 100 people):

• Allergic reaction, including skin reactions and edema (swelling) / allergic angioedema (sudden swelling).
• Sleep disorders.
• Dizziness, migraine, dizziness, somnolence, decreased sensitivity to skin stimulation.
• Visual disturbances.
• Tinnitus (ringing in the ears).
• Angina pectoris, chest pain, tachycardia (increased heart rate).
• Hypotension (low blood pressure).
• Dyspnea, nosebleeds.
• Gastrointestinal and abdominal pain, diarrhea, nausea, vomiting, dry mouth, dyspepsia (indigestion), constipation, stomach upset.
• Transient increase in liver enzymes.
• Muscle pain.
• Increased urine production and emission.

Frequency not known (cannot be estimated from available data):

• Gingival alterations.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nitrendipine Stada

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

Store in the original packaging to protect from light.

Nitrendipine is sensitive to light; therefore, it is recommended to keep the tablets in the blister pack inside the original packaging until the time of administration.

This medication, stored in its original packaging and under normal humidity and temperature conditions, has a shelf life of 60 months.

6. Package contents and additional information

Composition of Nitrendipine Stada

The active ingredient is nitrendipine. Each tablet contains 20 mg of nitrendipine.

The other ingredients are cornstarch, microcrystalline cellulose, povidone, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and package contents

Nitrendipine Stada tablets are round, light yellow in color, and have a score line on one side.

They come in blister packs containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

or

Bayer Healthcare Manufacturing SRL

Via delle Groane, 126

Garbagnate-Milanese CP:20024

Italy

Date of the last revision of this leaflet:June 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.