Salativ

Italy
Brand name Salativ
Form drops, oral solution
Active substance / Dosage
NIFEDIPINE
Prescription type Prescription only
ATC code
C08CA05
Registration number 051004
Manufacturer SO.SE.PHARM S.R.L. SOCIETA' DI SERVIZIO PER L'INDUSTRIA FARMACEUTICA ED AFFINI

Patient Information Leaflet
Salativ 20mg/mL oral drops, solution
Nifedipine
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet. 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Salativ is and what it is used for
  2. What you need to know before taking Salativ
  3. How to take Salativ
  4. Possible side effects
  5. How to store Salativ
  6. Contents of the pack and other information

1. What Salativ is and what it is used for

Salativ contains the active substance nifedipine. Nifedipine belongs to a group of medicines called calcium channel blockers (calcium antagonists), which work by dilating blood vessels, thereby reducing blood pressure and increasing blood supply to the heart muscle.
Salativ is indicated in adults for the treatment of:

  • a heart condition characterized by reduced blood flow to the heart (ischaemic heart disease), which manifests as chest pain (chronic stable angina or effort angina, and vasospastic angina, also known as variant angina or Prinzmetal's angina)
  • high blood pressure (arterial hypertension)
  • sudden episodes of high blood pressure (hypertensive crises)
  • Raynaud's syndrome (primary and secondary), a condition characterized by impaired blood circulation to the extremities of the body.

2. What you need to know before taking Salativ

Do not take Salativ

  • if you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant or suspect you may be pregnant, or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
  • if you have severe narrowing (stenosis) of the aorta (an artery of the heart)
  • in case of cardiovascular shock (a drop in blood pressure with severe reduction in heart function)
  • if you are currently taking rifampicin (an antibiotic) (see section “Other medicines and Salativ”)
  • if you suffer from heart disease characterized by sudden chest pain that worsens over time (unstable angina pectoris)
  • if you have had a heart attack and less than 4 weeks have passed.

Warnings and precautions
Talk to your doctor or pharmacist before taking Salativ.
Take this medicine with caution and always under medical supervision in the following cases:

  • if you have very low blood pressure (below 90 mmHg)
  • if you suffer from heart failure (a serious heart condition)
  • if you suffer from liver impairment (a serious liver disease). In this case, your blood pressure should be closely monitored and, if necessary, your doctor may reduce your dose of nifedipine.
  • if you are being treated with beta-blockers or other medicines for high blood pressure (see section “Other medicines and Salativ”)
  • if you are undergoing dialysis (a medical treatment used to filter the blood)
  • if you suffer from severe high blood pressure (malignant hypertension)
  • if you have severe kidney disease (renal failure) with reduced blood volume (hypovolemia)
  • if you have diabetes (a condition characterized by high blood sugar levels), or if you are at risk of developing diabetes. In this case, you should carefully monitor your blood glucose levels and, if high levels occur, your doctor will advise you to stop treatment (see section 4 “Possible side effects”).
  • if during pregnancy you experience an emergency condition such as eclampsia, a serious, potentially fatal condition characterized by high blood pressure and seizures, and you are receiving intravenous magnesium sulfate, because you may experience excessive lowering of blood pressure, which could harm both you and your baby (see sections “Do not take Salativ” and “Pregnancy, breastfeeding and fertility”)
  • if you are breastfeeding (see sections “Do not take Salativ” and “Pregnancy, breastfeeding and fertility”)

During treatment with Salativ, you may experience excessive lowering of blood pressure,
leading to increased heart rate (tachycardia) and possible heart and circulatory problems.
Additionally, particularly at the beginning of treatment, you may experience chest pain (angina pectoris).
If this medicine has been prescribed for chest pain, consult your doctor, as you may experience an increase in the frequency, duration, and intensity of chest pain, especially at the beginning of treatment.
In rare cases, heart attacks have been reported, although it is not known whether these events were due to the underlying disease.
At the beginning of treatment and until your doctor has precisely determined the appropriate dose for you, you must carefully monitor your blood pressure.
Children and adolescents
The use of Salativ is not recommended in children and adolescents under 18 years of age, as only limited safety and efficacy data are available in this population.
Other medicines and Salativ
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

  • rifampicin (an antibiotic). Do not take rifampicin together with Salativ because the effect of Salativ will be significantly reduced (see section “Do not take Salativ”)
  • tacrolimus (a medicine used if you have had an organ transplant)
  • quinidine, digoxin (medicines used for heart disorders)
  • medicines used to lower high blood pressure such as:
    • diuretics
    • beta-blockers. In this case, your doctor will monitor you closely because you may experience a marked drop in blood pressure.
    • ACE inhibitors
    • AT-1 antagonists
    • other calcium antagonists (other medicines similar to Salativ)
    • α-adrenergic blocking agents
    • 5-phosphodiesterase inhibitors (medicines used to treat erectile dysfunction)
    • α-methyldopa
  • medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital), as they may reduce the amount of Salativ in the blood and thus its effect. Your doctor may increase your dose of Salativ.

Also, inform your doctor if you are taking any of the following medicines:

  • macrolide antibiotics (a class of antibiotics, e.g. erythromycin)
  • quinupristin/dalfopristin, a combination of two antibiotics
  • diltiazem (a medicine used to treat high blood pressure)
  • medicines used to treat HIV infection (e.g. ritonavir)
  • medicines used for fungal skin infections (e.g. ketoconazole)
  • medicines used to treat depression (fluoxetine and nefazodone)
  • valproic acid (a medicine used to treat epilepsy)
  • cimetidine (a medicine used for stomach ulcers)
  • cisapride (a medicine used for gastroesophageal reflux) These medicines may increase the amount of Salativ in the blood, potentially increasing its effects: your doctor will advise you to monitor your blood pressure and, if necessary, may reduce your dose of Salativ.

Laboratory tests

  • This medicine may cause false increases in urinary vanillylmandelic acid levels when measured by spectrophotometric methods. Therefore, inform your doctor or healthcare provider that you are taking this medicine before undergoing this type of test.

Salativ with food and drink
Avoid consuming grapefruit or grapefruit juice while taking Salativ, as it may cause a significant drop in blood pressure. If you regularly drink grapefruit juice, this effect may last for more than 3 days after stopping.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Salativ if you are pregnant. (See section “Do not take Salativ”)
Your doctor may prescribe this medicine only if strictly necessary. If you are pregnant and your doctor has prescribed Salativ for severe hypertension that cannot be treated with other medicines, for example if you have eclampsia (a serious pregnancy-related condition), and you are receiving intravenous magnesium sulfate (a medicine used to treat eclampsia), your blood pressure must be closely monitored because you may experience excessive lowering of blood pressure, which could harm both you and your baby.
Breastfeeding
Do not take Salativ if you are breastfeeding. (See section “Do not take Salativ”), because nifedipine passes into breast milk and its effects on the newborn are unknown. Your doctor may prescribe this medicine only if strictly necessary. In this case, you should interrupt breastfeeding for 3–4 hours after taking this medicine.
Fertility
If you are a man experiencing difficulty conceiving through in vitro fertilization, calcium antagonists such as nifedipine should be considered as a possible cause.
Driving and using machines
This medicine may affect your ability to drive vehicles or operate machinery, especially at the beginning of treatment, when changing your medication, or when consuming alcoholic beverages.

3. How to take Salativ

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine the most appropriate dose for you, the duration of treatment, and will evaluate whether to increase or decrease the dose throughout the course of therapy.

Adults

  • Heart disease (ischaemic heart disease) presenting as chest pain (angina pectoris)
  • High blood pressure (arterial hypertension)
  • Raynaud's syndrome (a disorder of blood circulation)

The recommended dose is: 10 drops (= 10 mg), 3 times daily.
If necessary, your doctor may gradually increase the dose up to a maximum of 20 drops (= 20 mg), 3 times daily (= 60 mg total).
If your prescribed dose is 20 drops 3 times daily, you must wait at least 2 hours between one dose and the next.

  • Hypertensive crisis (sudden increase in blood pressure)

The recommended dose is: 10 or 20 drops (= 10 or 20 mg), once daily.
If the effect on blood pressure is insufficient with this dose, your doctor may prescribe an additional 10 drops (= 10 mg) to be taken approximately 30 minutes after the first dose. If necessary, your doctor may reduce the intervals between doses and/or increase the dose, and you will be kept under close medical supervision, as this may increase the risk of hypotension (excessive lowering of blood pressure).

Dilute the drops in water and take immediately.
Take the drops undiluted sublingually if a particularly rapid effect is desired.

When to take Salativ
Take this medicine preferably away from meals.

Use in patients with liver problems
Your doctor will carefully monitor your blood pressure values and may decide to prescribe a lower dose of Salativ.

Use in children and adolescents
The use of Salativ is not recommended in children and adolescents under 18 years of age.

If you take more Salativ than you should
In case of accidental ingestion/overdose of Salativ, contact your doctor immediately or go to the nearest hospital.

In cases of severe intoxication with Salativ, symptoms may include:

  • disturbances of consciousness up to coma
  • low blood pressure
  • heart rhythm disturbances, i.e. increased or decreased heart rate (tachycardia/bradycardia)
  • increased blood sugar (hyperglycaemia)
  • increased acid levels in the blood (metabolic acidosis)
  • lack of oxygen (hypoxia)
  • low blood pressure with severe reduction in heart function and lung swelling (cardiogenic shock with pulmonary oedema).

If you forget to take Salativ
Do not take a double dose to make up for the missed dose.

If you stop taking Salativ
Do not stop treatment with this medicine abruptly, as discontinuation must occur gradually and under strict medical supervision.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Contact your doctor immediately if, during treatment with Salativ, you experience any of the following serious side effects; your doctor will explain how to discontinue use of the medicine:

  • Anaphylactic/anaphylactoid reaction
  • Swelling of hands, feet, ankles, face, lips, tongue and/or throat (allergic edema/angioedema)

Additionally, if you have diabetes (a disease characterized by excess sugar in the blood) or are at risk of developing diabetes, you may experience increased blood sugar levels (hyperglycemia) during treatment with Salativ. If this occurs, contact your doctor immediately; your doctor will explain how to discontinue use of the medicine.

The following side effects have been observed and reported during treatment with Salativ, with the following frequencies:

Common (may affect up to 1 in 10 people)

  • Headache
  • Swelling due to fluid retention (edema)
  • Dilation of blood vessels (vasodilation)
  • Constipation
  • Feeling unwell (malaise)

Uncommon (may affect up to 1 in 100 people)

  • Allergic reaction
  • Anxiety reactions
  • Sleep disorders
  • Dizziness
  • Recurrent moderate to severe headache (migraine)
  • Vertigo
  • Tremor
  • Visual disturbances
  • Increased heart rate (tachycardia)
  • Awareness of heartbeats (palpitations)
  • Decreased blood pressure (hypotension)
  • Fainting (syncope)
  • Nosebleed (epistaxis)
  • Nasal congestion (nasal congestion)
  • Stomach and intestinal pain (gastrointestinal and abdominal pain)
  • Nausea
  • Difficulty digesting (dyspepsia)
  • Excessive passage of intestinal gas (flatulence)
  • Dry mouth
  • Transient increase in liver enzymes indicating liver function (liver enzymes)
  • Skin irritation (erythema)
  • Muscle cramps
  • Swelling of bone joints
  • Excessive urine production (polyuria)
  • Difficulty urinating (dysuria)
  • Erectile dysfunction
  • Generalized pain (non-specific pain)
  • Chills

Rare (may affect up to 1 in 1,000 people)

  • Itching (pruritus)
  • Red, itchy skin rash (urticaria)
  • Skin rash
  • Tingling or numbness in legs, arms, or other body parts (paresthesia)
  • Altered sensation to stimuli (dysesthesia)
  • Enlargement of the gums (gingival hyperplasia)

Not known (frequency cannot be estimated from available data)

  • Reduction in white blood cells (agranulocytosis/leukopenia)
  • Increased blood sugar (hyperglycemia)
  • Decreased sensitivity (hypoesthesia)
  • Drowsiness
  • Eye pain
  • Chest pain (angina pectoris)
  • Breathing difficulties (dyspnea, pulmonary edema)
  • Vomiting
  • Reduced function of the muscle connecting the esophagus to the stomach (gastroesophageal sphincter insufficiency)
  • Yellowing of the skin and whites of the eyes (jaundice)
  • Severe skin disease characterized by redness, blistering lesions, and areas of skin detachment (toxic epidermal necrolysis)
  • Allergic reaction due to light sensitivity (photosensitivity allergic reaction)
  • Purple spots on the skin due to bleeding from small blood vessels (palpable purpura)
  • Bone pain (arthralgia)
  • Muscle pain (myalgia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salativ

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
After first opening, the product should be used within 1 year.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Salativ contains

  • the active substance is nifedipine (1 mL contains 20 mg of nifedipine, equivalent to 20 drops)
  • the other component is polyethylene glycol (PEG 200)

Description of the appearance of Salativ and pack contents
It is a clear yellow solution, contained in a 30 mL amber glass bottle coated with black,
supplied with a dropper and tamper-evident cap.
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy