NIFE-PAR 5 mg/mL ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

nife-par 5 mg / ml oral solution

Nifedipine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

nife-par is indicated to delay imminent preterm labor in pregnant women who present:

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

This medication is for hospital use only.

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

Do not take nife-par:

• If you are allergic to nifedipine or any of the other components of this medication (listed in section 6).
• If you are being treated with rifampicin.
• If you are in the first 24 weeks of pregnancy, or in case of:
• Premature rupture of membranes after 30 weeks of gestation
• Fetal growth restriction and abnormal fetal heart rate
• Antepartum hemorrhage requiring immediate delivery
• Fetal death
• Suspected intrauterine infection

• Placental abruption
• Any other condition in the mother or fetus for which continuation of pregnancy is hazardous

• If you are in cardiovascular shock (the heart is so damaged that it is unable to supply enough blood to the body's organs), unstable angina, or if you have recently suffered a acute myocardial infarction.
• If you have severe hypotension, overt heart failure, and severe aortic valve obstruction (a part of the heart).

Warnings and precautions

Be careful with nife-par

• If you have liver disease.
• If you have diabetes.
• In case of pre-eclampsia.
• It is recommended to monitor maternal blood pressure and uterine function during administration.

Taking nife-par with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. Certain medications may interact with nife-par; in these cases, your doctor will need to adjust the dose or interrupt treatment with one of the medications. 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 medications, such as indinavir, ritonavir, saquinavir, amprenavir, nelfinavir,

delavirdine

• Medications to reduce high blood pressure, such as diltiazem
• Immunosuppressive medications, such as tacrolimus
• Cimetidine (medication to treat stomach ulcers)
• Cisapride (medication for heartburn)

Taking nife-par with food and drinks

Do not drink grapefruit juice during treatment with nifedipine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

Driving and using machines

Not applicable.

nife-par contains ethanol and yellow-orange colorant

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

The alcohol in this medication may affect children. The effects that may appear are changes in behavior and drowsiness. It may also affect their ability to concentrate and perform physical activities.

The amount of alcohol in this medication may affect your ability to drive and use machines because it can alter your judgment and reaction time.

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

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

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

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medication.

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

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

Follow exactly the administration instructions of this medication indicated 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.

The recommended dose is:

Initial dose (first hour):

• 2.0 ml (10.0 mg of nifedipine).
• If contractions do not subside, administer a new dose of 1.5 ml (7.5 mg of nifedipine) at 15 minutes. This new dose of 1.5 ml (7.5 mg of nifedipine) can 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 dose administered, the following regimen will be continued:

Maintenance dose (next 6-48 hours):

-3 ml (15 mg of nifedipine), every 6-8 hours, as needed.

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

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

Instructions for correct administration of the solution

Open the vial and insert the syringe, included in the packaging, by pressing on the perforated cap hole. Invert the vial and withdraw the necessary dose.

If you take more nife-par than you should

If you have taken more nife-par than you should, consult your doctor immediately or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication 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 other 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 gets them.

Frequent: (at least 1 in 100 patients)

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

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

• Allergic reaction: allergic edema of skin and mucous membranes (swelling), laryngeal edema.
• Anxiety reactions, sleep disturbances, agitation, nervousness.
• Dizziness, migraine, and tremor.
• Visual disturbances.
• Tachycardia (rapid heart rate), palpitations, angina pectoris.
• Hypotension, postural hypotension, fainting.
• Epistaxis (nasal bleeding), nasal congestion, dyspnea (difficulty breathing), chest pain.

- Abdominal and gastrointestinal pain, dyspepsia (difficult digestion), flatulence (gas), dry mouth, diarrhea.

• Alteration of liver function test results.
• Rash, sweating.
• Muscle cramps, joint swelling.
• Increased urination.
• Unspecific pain (pain of unknown cause), chills, asthenia (weakness).

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

• Feeling of tingling in the limbs, increased sensitivity to touch.
• Gingival hyperplasia (increase in gum thickness).
• Abdominal distension (swelling), loss of appetite, vomiting.
• Muscle pain.

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

• Hypotension that can cause cardiac problems.
• Agranulocytosis, purpura (alteration of certain blood parameters).
• Hyperglycemia (alteration of glucose test in blood)
• Exfoliative dermatitis (skin peeling), photosensitivity dermatitis (exaggerated skin response to sunlight), urticaria.

Acute pulmonary edema has been reported (frequency unknown)

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

Reporting of side effects

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

5. Storage of nife-par 5 mg / ml oral solution

Keep this medication out of sight and reach of children.

Keep the vial in the box to protect it from light.

This medication does not require any special storage temperature.

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. The unused solution should be disposed of in accordance with local requirements. This will help protect the environment.

6. Contents of the pack and further information

Composition of nife-par

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

Appearance of the product and pack contents

Topaz glass vial with screw cap and stopper plus oral syringe.

Each vial 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 last revision of this leaflet:October 2019

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.es/