PATIENT LEAFLET: INFORMATION FOR THE USER

Manidipine Sandoz 10 mg tablets, 20 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start using this medicine.

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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Manidipine Sandoz is and what it is used for
Before you take Manidipine Sandoz
How to take Manidipine Sandoz
Possible side effects
How to store Manidipine Sandoz
Further information

1. WHAT MANIDIPINE SANDOZ IS AND WHAT IT IS USED FOR

Manidipine Sandoz tablets contain 10 mg of the active substance manidipine, which
belongs to a group of medicines called dihydropyridine calcium antagonists.
Manidipine Sandoz tablets contain 20 mg of the active substance manidipine, which
belongs to a group of medicines called dihydropyridine calcium antagonists.
Manidipine is indicated for the treatment of mild to
moderate essential hypertension (high blood pressure).
Manidipine works by relaxing blood vessels: this reduces arterial pressure.

2. BEFORE TAKING MANIDIPINE SANDOZ

Do not take Manidipine Sandoz

if you are allergic (hypersensitive) to manidipine, to other calcium antagonists, or to any of the excipients in Manidipine Sandoz tablets (for a list of excipients, see section 6).
if you suffer from unstable angina (chest pain not caused by stress or exertion, or nocturnal pain), or if you have had a myocardial infarction within the last 4 weeks
if you suffer from untreated congestive heart failure
if you have severe renal impairment (creatinine clearance <10 ml/min)
if you have moderate to severe hepatic impairment
if you are a child.

Take special care with Manidipine Sandoz, especially in the following cases

if you have mild liver damage, as the effects of manidipine may be increased (see section 3 “How to take Manidipine Sandoz”)
if you are an elderly patient, a dose reduction is required (see section 3 “How to take Manidipine Sandoz”)
if you suffer from heart disease
if you are taking other medicines (see “Taking Manidipine Sandoz with other medicines”).

Taking Manidipine Sandoz with other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken, any other
medicines, including those not requiring a prescription, or medications for any of the
following conditions:

high blood pressure (such as diuretics and/or beta-blockers)
viral and bacterial infections
mental disorders
irregular heartbeat (such as amiodarone, quinidine, digoxin)
allergies (such as terfenadine, astemizole).

Taking Manidipine Sandoz with food and drinks
During treatment with Manidipine Sandoz, patients must not consume alcohol or
grapefruit juice.
Pregnancy and breastfeeding
Manidipine Sandoz must not be used during pregnancy. The use of manidipine
should be avoided during breastfeeding. If treatment with manidipine is necessary,
breastfeeding must be discontinued.
Fertility
In some patients treated with calcium antagonists, abnormalities in sperm head morphology have been reported, which could impair fertilization.
Consult your doctor before taking any medicine.
Driving and using machines
Since dizziness may occur, exercise particular caution while driving or operating
machinery.
Important information about some excipients in Manidipine Sandoz
Manidipine Sandoz contains lactose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking manidipine.

3. HOW TO TAKE MANIDIPINE SANDOZ

Always take Manidipine Sandoz exactly as prescribed by your
doctor. If you have any doubts, consult your doctor.
If you feel that the effect of Manidipine Sandoz is too strong or too weak, please consult your
doctor or pharmacist.
Children must not take manidipine.
Your doctor will determine the duration of treatment. Do not stop treatment unless instructed
by your doctor.
The tablets should be taken in the morning after breakfast, with some liquid, and must not be chewed.
The usual initial dose is 10 mg once daily.
If after 2–4 weeks of treatment the antihypertensive effect of manidipine is
insufficient, your doctor may increase the dose to 20 mg once daily.
If you are elderly or suffer from renal or hepatic impairment, your doctor may
prescribe a lower dose (10 mg once daily).
If you take more Manidipine Sandoz than you should
If you (or someone else) have taken an excessive number of tablets
at the same time, or if you suspect that a child has ingested one of the tablets, go
immediately to the emergency department of the nearest hospital or contact your doctor.
As with other calcium antagonists, overdose may cause excessive peripheral vasodilation,
leading to a reduction in arterial blood pressure and an increase in heart rate.
If you forget to take Manidipine Sandoz
If you miss a dose, take it as soon as possible, then continue with your regular dosing schedule.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Manidipine Sandoz
Consult your doctor before stopping treatment with Manidipine Sandoz.
If you have any questions about the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Manidipine can cause adverse reactions, although not everyone experiences them. The following adverse reactions may occur during treatment with Manidipine Sandoz.

Common (≥1/100, <1/10): headache, dizziness, vertigo, swelling due to fluid retention, palpitations, hot flushes.

Uncommon (≥1/1,000, <1/100): skin tingling sensations, weakness or lack of energy, rapid heartbeat, low blood pressure, difficulty breathing, nausea, vomiting, constipation, dry mouth, digestive disturbances, skin rashes, eczema, increased liver enzymes and/or increased renal parameters (your doctor is aware of this).

Rare (≥1/10,000, <1/1,000): drowsiness, numbness, chest pain, angina, high blood pressure, stomach ache, abdominal pain, skin redness, itching and irritability.

Very rare (<1/10,000): myocardial infarction, inflammation of the gums and excessive gum growth, which usually resolve upon discontinuation of treatment. In isolated cases, patients with pre-existing angina may experience an increase in frequency, duration, and intensity of these symptoms.

Frequency not known: muscle pain, breast swelling with or without breast tenderness in men (gynecomastia), extrapyramidal syndrome has been reported with some calcium antagonists.

If any of these adverse reactions worsens, or if you notice any adverse reaction not listed in this leaflet, inform your doctor.

5. HOW TO STORE MANIDIPINE SANDOZ

Keep Manidipine Sandoz out of the reach and sight of children.
Do not use Manidipine Sandoz after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Manidipina Sandoz 10 mg contains
The active substance is manidipine hydrochloride 10 mg.
The excipients are monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.
What Manidipina Sandoz 20 mg contains
The active substance is manidipine hydrochloride 20 mg.
The excipients are monohydrate lactose, maize starch, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, riboflavin.
Description of the appearance of Manidipina Sandoz and contents of the pack
Manidipina Sandoz is available in two strengths: 10 mg and 20 mg.
The 10 mg tablets are round, convex, yellow in colour, with a central break line.
The 20 mg tablets are oval, convex, yellow in colour, with a central break line.
Manidipina Sandoz is available in the following pack sizes:
10 mg: 14, 28, 30, 90 tablets
20 mg: 14, 28, 30, 90 tablets
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Responsible manufacturer for batch release
Abiogen Pharma S.p.A.
Via Meucci 36,
56121 Ospedaletto
Pisa - Italy
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia
This summary of product characteristics was last approved on