PATIENT INFORMATION LEAFLET

nife-par 5 mg / ml oral solution

Nifedipine

Read this 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking 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 additional information

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

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

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

This medication is for hospital use only.

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 retardation and abnormal fetal heart rate
• Antepartum hemorrhage requiring immediate delivery
• Fetal death
• Suspected intrauterine infection

• Premature placental abruption
• Any other condition in the mother or fetus that makes continuing the pregnancy hazardous

- If you are experiencing cardiovascular shock (the heart has been so damaged that it is unable to supply enough blood to the body's organs), unstable angina, or have recently had an acute myocardial infarction.

- If you have severe hypotension, manifest cardiac insufficiency, and severe aortic valve obstruction (a part of the heart).

Warnings and precautions

Be especially careful with nife-par

- If you have any 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

Inform your doctor or pharmacist if you are using, or 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 discontinue 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

darunavir

- Medications to reduce elevated blood pressure, such as diltiazem

- Immunosuppressants, such as tacrolimus

- Cimetidine (medication to treat stomach ulcers)

- Cisapride (medication for heartburn)

Taking nife-par with food and beverages

Do not take grapefruit juice during treatment with nifedipine.

Pregnancy and lactation

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 operating machinery

No.

Nife-par contains ethanol and yellow-orange dye

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

The amount of alcohol contained in this medication may affect your ability to drive and operate machinery due to its potential to 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 contained 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 with your doctor or pharmacist before taking this medication.

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The administration route isoral. Yourdoctor will determine the appropriate dose for your specific 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-minute intervals. 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 continue:

Maintenance dose (next 6-48hours):

-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 treatment duration 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 bottle and insert the syringe, included in the packaging, by pressing on the perforated cap. 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, consult your doctor immediately or call the Toxicological 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 compensate for the missed doses.

If you interrupt treatment with nife-par

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Frequent:(in at least 1 in 100 patients)

- Headache, dizziness.

- Edema (swelling) and vasodilation (widening of blood vessels).

- Constipation, nausea.

- Feeling of discomfort.

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

- Allergic reaction: skin and mucous membrane edema (swelling), laryngeal edema.

- Anxiety reactions, sleep disturbances, agitation, nervousness.

- Dizziness, migraine, and tremors.

- 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 (difficult digestion), flatulence (gas), dry mouth, diarrhea.

- Alteration of liver function test results.

- Eruption, sweating.

- Muscle cramps, joint swelling.

- Increased urine production and emission.

- Nonspecific pain (pain of unknown cause), chills, asthenia (weakness).

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

- Tingling sensation in the extremities, increased sensitivity to touch.

- Gingival hyperplasia (increased thickness of the gums).

- Abdominal distension, loss of appetite, vomiting.

- Muscle pain.

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

- Hypotension that may cause cardiac problems.

- Agranulocytosis, purpura (alteration of certain blood parameters).

- Hyperglycemia (alteration of blood glucose test)

- Exfoliative dermatitis (skin peeling), dermatitis caused by photosensitivity (exaggerated skin response to sunlight), urticaria.

There have been cases of acute pulmonary edema (unknown frequency)

A meta-analysis of clinical trials conducted with nifedipine as a tocolytic showed that the incidence of adverse reactions was significantly higherwith 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 that does not appear in this prospectus. You can also report them directly through the Spanish System of 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.

Keep the bottle 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 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. Unused solution should be disposed of in accordance with local requirements. This will help protect the environment.

Nife-par Composition

-The active ingredient is nifedipine. Each milliliter of solution contains 5 mg of nifedipine.

-The other components are: 96° ethanol, glycerol, sodium cyclamate, sodium saccharin, hydrochloric acid 37% (for pH adjustment), yellow-orange food dye (E-110), lemon essence, and purified water.

Product appearance and packaging contents

Topaz glass vialwith screw cap andstopper with oral dropper.

Each vial contains 30 ml of oral solution.

Marketing authorization holder and manufacturer responsible

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Last review date of this leaflet:October 2019

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