Diltiazem Sandoz BV

Patient Information Leaflet

Diltiazem Sandoz BV 200 mg prolonged-release hard capsules

Equivalent medicine
Please 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 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diltiazem Sandoz BV is and what it is used for

Diltiazem Sandoz BV contains a substance called diltiazem, which belongs to a class of medicines known as “calcium channel blockers”.
Diltiazem Sandoz BV is used to treat:

• high blood pressure
• angina (chest pain).

This medicine works by widening the blood vessels. This helps reduce blood pressure and makes it easier for the heart to pump blood around the body, thereby helping to prevent chest pain caused by angina.

2. What you need to know before taking Diltiazem Sandoz BV

Do not take Diltiazem Sandoz BV

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• if your heart rate is very slow – less than 40 beats per minute
• if you have heart failure and disorders related to blood flow to the lungs. With these conditions, you may experience shortness of breath and swelling of the ankles
• if you suffer from other serious heart disorders, including irregular heartbeat (unless you have a properly functioning pacemaker)
• if you are receiving an infusion of dantrolene used to treat severe muscle spasms or high fever (a condition called "malignant hyperthermia") (see section below "Other medicines and Diltiazem Sandoz BV")
• if you are already taking a medicine containing ivabradine to treat certain heart diseases. If any of these conditions applies to you, do not take this medicine. If you have any doubts, consult your doctor or pharmacist before taking Diltiazem Sandoz BV.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Sandoz BV:

• if you have any other heart disorder, apart from angina or those described in the previous section "Do not take Diltiazem Sandoz BV"
• if you are due to undergo anesthesia (for example, due to surgery)
• if you are at risk of mood disorders, including depression
• if you are at risk of intestinal disorders
• if you have liver problems
• if you have kidney problems
• if you are elderly.

If any of these conditions applies to you (or you are unsure), consult your doctor or pharmacist before taking Diltiazem Sandoz BV.
Other medicines and Diltiazem Sandoz BV
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, because Diltiazem Sandoz BV may affect how some other medicines work. Also, some medicines may affect how Diltiazem Sandoz BV works.
In particular, do not take this medicine and inform your doctor if you are taking:

• dantrolene (an infusion) used to treat severe muscle spasms or high fever (a condition called "malignant hyperthermia")
• nifedipine
• ergot derivatives (ergotamine, dihydroergotamine)
• cisapride
• sertindole
• pimozide
• ivabradine

Take special care if you are using Diltiazem Sandoz BV together with the following medicines:

• medicines that may cause QT prolongation and torsades de pointes, such as phenothiazines, bepridil, certain oral macrolides (such as erythromycin), terfenadine, and class I and III antiarrhythmics, methadone.

Diltiazem Sandoz BV may increase the effect of the following medicines:

• medicines used for high blood pressure, such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol
• medicines used to treat irregular heartbeat, such as amiodarone, digoxin and dronedarone
• medicines used to treat angina, such as nitroglycerin or isosorbide trinitrate
• medicines used to treat high cholesterol levels, such as simvastatin, fluvastatin and atorvastatin
• medicines used to treat insomnia and anxiety, such as triazolam and midazolam
• tricyclic antidepressants, used to treat depression/mood disorders
• medicines used for epilepsy, such as carbamazepine, phenobarbital, phenytoin
• theophylline, used for respiratory disorders
• lithium, used for certain types of mental illness
• methylprednisolone, used to treat inflammation and allergic reactions
• diuretics, used in the treatment of hypertension
• anesthetics, used during surgical procedures
• colchicine, used to treat gout
• immunosuppressants (cyclosporine, tacrolimus, sirolimus, everolimus), used to prevent organ rejection after transplantation.

Diltiazem Sandoz BV may reduce the effectiveness of the following medicine:

• rifampicin, used to treat tuberculosis.

The following medicines may increase the effect of Diltiazem Sandoz BV:

• medicines used to treat gastric ulcers, such as cimetidine and ranitidine.

If any of the above conditions applies to you (or you are unsure),
consult your doctor or pharmacist before taking Diltiazem Sandoz BV.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor for advice before taking this medicine.

• Diltiazem Sandoz BV is not recommended during pregnancy, as it may cause problems for the baby.
• Breastfeeding is not recommended during treatment with Diltiazem Sandoz BV, as small amounts may pass into breast milk.
• Diltiazem Sandoz BV may impair fertility and cause fetal abnormalities.

Driving and using machines
While taking this medicine, you may experience dizziness. If this happens, do not drive
and do not operate tools or machinery.

3. How to take Diltiazem Sandoz BV

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist. Also consult your doctor if you think that the
effect of the medicine is too weak or too strong. Do not change the dose on your own initiative.
Instructions for use

• Take this medicine by mouth.
• Do not break, crush, or chew the capsules.
• Swallow the capsules whole, with a glass of water.
• Take the medicine before or during a meal.

How much medicine to take
Adults

• The usual starting dose is one capsule of Diltiazem Sandoz BV 200 mg prolonged-release hard capsules once daily.

If necessary, your doctor may increase the dose. Other possible doses are:

• One capsule of diltiazem 300 mg prolonged-release hard capsules once daily
• Two capsules of Diltiazem Sandoz BV 200 mg prolonged-release hard capsules once daily
• One capsule of diltiazem 300 mg prolonged-release hard capsules and one capsule of Diltiazem Sandoz BV 200 mg prolonged-release hard capsules once daily.

Elderly patients over 65 years or adults with liver or kidney problems

• Your doctor must monitor you particularly closely at the beginning of treatment.
• The usual starting dose is one capsule of Diltiazem Sandoz BV 200 mg prolonged-release hard capsules once daily. If necessary, your doctor may increase the dose to:
• One capsule of diltiazem 300 mg prolonged-release hard capsules once daily.

Use in children
Diltiazem Sandoz BV must not be given to children.
Sun protection
During treatment with this medicine, you should use sun protection.
Medical examinations
While you are taking this medicine, your doctor may prescribe periodic tests,
which may include monitoring of heart function and blood tests to check liver and kidney function.
If you take more Diltiazem Sandoz BV than you should
If you take more capsules than prescribed, inform your doctor or go immediately to the emergency department of a hospital. Take the medicine package with you,
so that healthcare professionals can see which medicine you have taken. You may experience
the following effects: dizziness or feeling weak, blurred vision, chest pain,
shortness of breath, fainting, abnormally fast or slow heartbeat, coma, difficulty
speaking, and confusion.
If you forget to take Diltiazem Sandoz BV
If you forget a dose, take it as soon as you remember. However, if it is almost time for
your next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.
If you stop taking Diltiazem Sandoz BV
Continue taking Diltiazem Sandoz BV until your doctor tells you to stop.
Do not stop taking Diltiazem Sandoz BV just because you feel better. If you stop
taking the medicine, your condition may worsen.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Diltiazem Sandoz BV immediately and consult a doctor
or go to hospital straight away if:

• you develop an allergic reaction. Signs may include: a red or raised rash, difficulty swallowing or breathing, swelling of the lips, face, eyelids, throat or tongue
• you develop blisters or peeling of the skin around the lips, eyes, mouth, nose or genitals, flu-like symptoms or fever. This could be a condition called "Stevens-Johnson syndrome"
• you develop a severe skin rash with blisters, causing layers of skin to peel off, exposing large areas of raw skin all over the body. You may feel generally unwell, have fever, chills or muscle pain. This could be a condition called "toxic epidermal necrolysis"
• you develop skin rashes or lesions characterized by a pink or red ring with a paler central area, which may be itchy, scaly or filled with fluid. These rashes are more likely to appear on the palms of the hands or soles of the feet. These may be signs of a serious allergic reaction to the medicine, called "erythema multiforme".

If you notice any of the following serious side effects, tell your doctor immediately –
urgent medical treatment may be needed:
Common (may affect up to 1 in 10 people)

• slow or irregular heartbeat
• very fast, irregular or forceful heartbeat (palpitations)

Frequency not known: frequency cannot be established from the available data

• Skin rash caused by narrowing or blockage of blood vessels (called "vasculitis")
• Shortness of breath, feeling tired with swelling of the ankles or legs. These may be signs of heart failure
• Unusual movements of the tongue, facial muscle spasms, rolling of the eyes or tremor
• High temperature, feeling tired, loss of appetite, stomach ache, feeling unwell. These may be signs of liver inflammation (called "hepatitis")
• Sunburn occurs more easily and is more severe than in people not taking Diltiazem Sandoz BV. You should use sun protection during treatment with this medicine
• Breast enlargement in men

If you experience any of the following side effects, tell your doctor as soon as possible:
Very common (may affect more than 1 in 10 people)

• Swelling in the lower parts of the legs

Common (may affect up to 1 in 10 people)

• Indigestion, stomach ache, constipation or diarrhoea

Uncommon (may affect up to 1 in 100 people)

• Dizziness, feeling lightheaded or faint when standing up or sitting down quickly (low blood pressure)

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

• Dry mouth
• Itching, skin rash characterized by swellings ("urticaria")

Frequency not known: frequency cannot be established from the available data

• Swelling of the gums

If any of the following side effects worsen or last longer than a few days,
tell your doctor or pharmacist:
Common (may affect up to 1 in 10 people)

• Headache
• Flushing (feeling of warmth)
• Feeling sick (nausea) or being sick (vomiting)
• General feeling of being unwell
• Weakness or tiredness
• Dizziness
• Redness of the skin

Uncommon (may affect up to 1 in 100 people)

• Difficulty sleeping
• Nervousness

Frequency not known: frequency cannot be established from the available data

• Mood changes, including depression
• Bleeding or bruising under the skin
• Gingival hyperplasia
• Decrease in platelet count (thrombocytopenia)

Blood tests
Diltiazem Sandoz BV may alter liver enzyme levels detected in blood tests. This may indicate that the liver is not functioning properly.
Other observations
Residue from the tablets of the prolonged-release formulations may pass into the stool. However, this has no clinical significance.
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: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diltiazem Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Diltiazem Sandoz BV contains

• Each prolonged-release hard capsule of Diltiazem Sandoz BV 200 mg contains 200 mg of the active substance diltiazem hydrochloride. The other ingredients are povidone, talc, ethylcellulose, stearic acid, gelatin and titanium dioxide (E171).

Description of the appearance of Diltiazem Sandoz BV and contents of the pack

• Diltiazem Sandoz BV 200 mg prolonged-release hard capsules are opaque capsules with white body and cap.

The capsules are supplied in blisters containing 7, 14, 28, 28x1, 30, 36, 50, 50x1, 56, 84, 90, 98,
100x1 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz B.V., Veluwezoom 22, 1327 AH Almere, The Netherlands
Local representative for Italy: Sandoz S.p.A., Largo U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero, Modena, Italy
Farmea, Rue Bouché Thomas, 10, ZAC D’Orgemont 49007 Angers Cedex, France
Sandoz B.V., Veluwezoom 22, 1327 AH Almere, The Netherlands
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Târgu-Mureș, Romania

This medicinal product is authorized in the European Economic Area countries
under the following names:
Portugal Diltiazem Sandoz
Belgium Diltiazem Sandoz 200 mg capsules met verlengde afgifte, hard
Diltiazem Sandoz 300 mg capsules met verlengde afgifte, hard
France Diltiazem Biostabilex LP 200 mg, gélule à libération prolongée
Diltiazem Biostabilex LP 300 mg, gélule à libération prolongée
Italy DILTIAZEM SANDOZ BV
Luxembourg Diltiazem Sandoz 200 mg gélules à libération prolongée
Diltiazem Sandoz 300 mg gélules à libération prolongée
Netherlands Diltiazem HCl Sandoz retard 200 mg, capsules met verlengde afgifte, hard
Diltiazem HCl Sandoz retard 300 mg, capsules met verlengde afgifte, hard