Prospect: Information for the User

Nitrendipino STADA 20 mg Tablets EFG

Read this entire prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Nitrendipino belongs to a group of medicines called anti-hypertensives (calcium antagonists), that is, medicines that reduce blood pressure.

Nitrendipino is indicated for the treatment of high blood pressure (elevated blood pressure) and isolated systolic hypertension in elderly patients.

Do not take Nitrendipino Stada:

• if you are allergic (hypersensitive) to the active ingredient or to 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 rifampicina.

Warnings and precautions

Consult your doctor before starting to take Nitrendipino Stada:

• if you are over 65 years old.
• if you have any liver disease.
• if you have already been or are being treated to lower blood pressure.
• if you have heart problems.
• if you have high blood pressure and a severe cerebrovascular disease.
• if you experience side effects at the beginning of treatment.
• in case of in vitro fertilization, as nitrendipino may decrease the chances of conception.

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

Children and adolescents

Nitrendipino should not be used in children or adolescents under 18 years old.

Use of Nitrendipino Stada with other medications

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

Certain medications may interact with nitrendipino; 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 elevated blood pressure.
• Muscle relaxants such as pancuronio
• Antibiotics such as rifampicina, eritromicina, quinupristina, or dalfopristina.
• Cardiotonic medications such as digoxina.
• Antiepileptic medications such as phenitoína, phenobarbital, carbamazepina, or ácido valpróico.
• Antiretroviral medications, such as ritonavir.
• Antifungal medications such as ketoconazol.
• Antidepressants such as fluoxetina or nefadozona.Medications that reduce stomach acid production, such as cimetidina or ranitidina.

Taking Nitrendipino Stada with food and drinks

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

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.

Nitrendipino is contraindicated during pregnancy and breastfeeding.

In vitro fertilization:

In isolated cases of in vitro fertilization, calcium antagonists such as nitrendipino have been associated with reversible biochemical changes in the head of spermatozoa that may lead to alterations in 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 operating machinery

Nitrendipino may limit the ability to drive cars or operate machinery, especially at the beginning of treatment.

Nitrendipino Stada contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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 another with dinner).

The tablet is usually taken without chewing with the help of a little liquid (not orange juice) after eating.

Remember to take your medication.

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

Use in patients with liver insufficiency

In patients with liver problems, the usual starting dose for treatment is 10 mg of nitrendipino (half a tablet of Nitrendipino Stada tablets).

If you take more Nitrendipino Stada than you should

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

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

If you forgot to take Nitrendipino Stada

Do not take a double dose to compensate for the missed doses. Take it as soon as possible and continue taking it according to the usual schedule.

If you interrupt treatment with Nitrendipino Stada

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent adverse effects (may affect up to 1 in 10 people):

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

Less frequent adverse effects (may affect up to 1 in 100 people):

• Allergic reaction including skin reactions and edema (swelling) / angioedema (sudden allergic swelling).
• Sleep disorders.
• Dizziness, migraine, vertigo, drowsiness, 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, nasal hemorrhage.
• Gastrointestinal and abdominal pain, diarrhea, nausea, vomiting, dry mouth, dyspepsia (heaviness in the stomach, indigestion), constipation, abdominal discomfort.
• Transient increase in liver enzymes.
• Muscle pain.
• Increased urine production and urination.

Unknown frequency (cannot be estimated from available data):

• Alterations of the gums.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Store in the original packagingto protect it from light.

Nitrendipino is sensitive to light, so it is recommended to keep the tablets in the blister pack within 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.

Composition of Nitrendipino Stada

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

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

Appearance of the product and contents of the packaging

Nitrendipino Stada tablets are round, yellowish-colored tablets with a notch on one face.

They are presented in blisters containing 30 tablets.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

STADA, S.L Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer responsible

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

or

Bayer Healthcare Manufacturing SRL

Via delle Groane, 126

Garbagnate-Milanese CP:20024

Italy

Last review date of this leaflet:June 2018

The detailed and updated information on this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.