NIFE-PAR 5 MG/ML ORAL SOLUTION

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

nife-par 5 mg / ml oral solution

Nifedipine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What nife-par 5 mg / ml oral solution is and what it is used for
2. What you need to know before taking nife-par 5 mg / ml oral solution
3. How to take nife-par 5 mg / ml oral solution
4. Possible side effects
5. How to store nife-par 5 mg / ml oral solution
6. Contents of the pack and other information

1. What nife-par 5 mg/ml oral solution is and what it is used for

The active substance, nifedipine, has a marked relaxing effect on the smooth muscle tissue of the uterine walls.

nife-par is indicated to delay imminent preterm delivery in pregnant women who have:

• Regular uterine contractions lasting at least 30 seconds and occurring at a frequency of 4 or more contractions every 30 minutes.
• Cervical dilation of 1 to 3 cm (0 to 3 cm in nulliparous women) and cervical effacement of more than 50%.
• Gestational age between 24 and 33 completed weeks.
• Normal fetal heart rate.

This medicine is for hospital use only.

2. What you need to know before taking nife-par 5 mg/ml oral solution

Do not take nife-par:

• If you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6).

• If you are being treated with rifampicin.

• If you are within the first 24 weeks of pregnancy, or if:

  • Premature rupture of membranes after 30 weeks of gestation
  • Fetal growth restriction and abnormal fetal heart rate
  • Prepartum uterine bleeding requiring immediate delivery
  • Fetal death
  • Suspected intrauterine infection

• Premature placental abruption

• Any other maternal or fetal condition where continuation of pregnancy is dangerous

• If you are in cardiovascular shock (the heart is so damaged it cannot supply enough blood to the body's organs), have unstable angina, or have recently suffered an acute myocardial infarction.

• If you have severe hypotension, manifest heart failure, or severe aortic valve obstruction (a part of the heart).

Warnings and precautions

Exercise special caution with nife-par

• If you have any liver disease.
• If you have diabetes.
• In cases of pre-eclampsia.
• Maternal blood pressure and uterine function should be monitored during treatment.

Taking nife-par with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Certain medicines may interact with nife-par; in such cases, your doctor may need to adjust the dose or discontinue treatment with one of the medicines. This is especially important when taking:

• Antibiotics such as rifampicin, erythromycin, quinupristin, or dalfopristin

• Antiepileptics such as phenytoin, phenobarbital, or carbamazepine; valproic acid

• Antidepressants such as fluoxetine or nefazodone

• Antifungals (against fungi), such as ketoconazole, itraconazole, or fluconazole

• Antiretroviral medicines, such as indinavir, ritonavir, saquinavir, amprenavir, nelfinavir,

• Delavirdine

• Medicines to lower high blood pressure, such as diltiazem

• Immunosuppressants, such as tacrolimus

• Cimetidine (a medicine used to treat stomach ulcers)

• Cisapride (a medicine for heartburn)

Taking nife-par with food and drink

Do not drink grapefruit juice during treatment with nifedipine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

nife-par is contraindicated during the first 24 weeks of pregnancy.

Nifedipine is excreted in breast milk. As a precaution, breastfeeding should be started 36 hours after the last dose.

Driving and using machines

Not applicable.

nife-par contains ethanol and orange-yellow dye

This medicine contains 0.88 g of ethanol per 2.0 ml dose. The amount in 2 ml of this medicine is equivalent to 17 ml of beer or 7 ml of wine.

The alcohol contained in this medicine may affect children. Possible effects include behavioral changes and drowsiness. It may also affect your ability to concentrate and perform physical activities.

The amount of alcohol in this medicine may affect your ability to drive and operate machinery, as it may impair your judgment and reaction capacity.

If you have epilepsy or liver problems, consult your doctor or pharmacist before taking this medicine.

The amount of alcohol in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

This medicine may cause allergic reactions because it contains orange-yellow dye (E-110). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take nife-par 5 mg/ml oral solution

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The route of administration is oral. Your doctor will determine the appropriate dose for your particular case.

Recommended dose:

Initial dose (first hour):

• 2.0 ml (10.0 mg of nifedipine).
• If contractions do not subside, administer a further dose of 1.5 ml (7.5 mg of nifedipine) after 15 minutes. This additional dose of 1.5 ml (7.5 mg of nifedipine) may be repeated every 15 minutes until contractions subside. The maximum dose during the first hour is 8 ml (40 mg).

Once contractions have subsided and 6 hours have passed since the last administered dose, continue with the following regimen:

Maintenance dose (next 6 – 48 hours):

• 3 ml (15 mg of nifedipine), every 6 – 8 hours, depending on response.

The maximum daily dose is 32 ml/day (160 mg of nifedipine).

The duration of treatment will be 48 hours, which may be extended depending on the evolution of the risk of threatened preterm delivery, but should not exceed 72 hours (3 days) in principle.

Instructions for correct administration of the solution

Open the bottle and insert the syringe provided in the package, pressing it into the pierced stopper's opening. Invert the bottle and withdraw the required dose.

If you take more nife-par than you should

If you have taken more nife-par than you should, contact your doctor immediately or call the Toxicology Information Service, Telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take nife-par

Do not take a double dose to make up for forgotten doses.

If you stop treatment with nife-par

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common: (at least 1 in 100 patients)

• Headache, dizziness.
• Edema (swelling) and vasodilation (dilation of blood vessels).
• Constipation, nausea.
• Feeling of malaise.

Uncommon: (at least 1 in 1,000 patients)

• Allergic reaction: allergic edema of skin and mucous membranes (swelling), swelling of the larynx.

• Anxiety reactions, sleep disturbances, agitation, nervousness.

• Dizziness, migraine, tremor.

• Visual disturbances.

• Tachycardia (rapid heart rate), palpitations, angina pectoris.

• Hypotension, postural hypotension, fainting.

• Epistaxis (nosebleed), nasal congestion, dyspnea (difficulty breathing), chest pain.

• Abdominal and gastrointestinal pain, dyspepsia (indigestion), flatulence (gas), dry mouth, diarrhea.

• Abnormal liver function test results.

• Rash, sweating.

• Muscle cramps, joint swelling.

• Increased urine secretion and output.

• Non-specific pain (pain of unknown cause), chills, asthenia (weakness).

Rare: (at least 1 in 10,000 patients)

• Tingling sensation in the limbs, increased sensitivity to touch.
• Gingival hyperplasia (thickening of the gums).
• Abdominal distension (swelling), loss of appetite, vomiting.
• Muscle pain.

Very rare: (less than 1 in 10,000 patients)

• Hypotension that may lead to cardiac problems.
• Agranulocytosis, purpura (alteration of certain blood parameters).
• Hyperglycemia (abnormal blood glucose test).
• Exfoliative dermatitis (skin peeling), photosensitivity dermatitis (exaggerated skin reaction to sunlight), urticaria.

Cases of acute pulmonary edema have been reported (frequency unknown).

A meta-analysis of clinical trials using nifedipine as a tocolytic showed that the incidence of adverse reactions was significantly higher with total daily doses exceeding 60 mg.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 nife-par 5 mg/ml oral solution

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

Keep the bottle in the outer carton to protect it from light.

No special storage conditions are required for this medicine.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused solution must be discarded according to local requirements. This will help protect the environment.

6. Contents of the container and other information

Composition of nife-par

• The active substance is nifedipine. Each ml of solution contains 5 mg of nifedipine.
• The other components are: 96% ethanol, glycerol, sodium cyclamate, sodium saccharin, hydrochloric acid 37% (for pH adjustment), orange yellow dye (E-110), lemon flavor, and purified water.

Appearance of the product and contents of the container

Amber glass bottle with screw cap and closure, plus an oral syringe.

Each bottle contains 30 ml of oral solution.

Marketing Authorization Holder and Manufacturer

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Date of the most recent revision of this leaflet: October 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/