180 mg, 240 mg, 300 mg prolonged- release tablets Diltiazem 
hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cardizem Unotard is and what it is used for 
2. What you need to know before you use Cardizem Unotard 
3. How to use Cardizem Unotard 
4. Possible side effects 
5. How to store Cardizem Unotard 6. Contents of the pack 
and other information 

What Cardizem Unotard is and what it is used for

Cardizem Unotard is a so-called calcium antagonist that inhibits the influx of calcium into certain cells. For the heart, it means a reduced amount of work and thus a reduced risk of overexertion of the heart muscle. The risk of angina decreases. With high blood pressure, the blood vessels dilate, causing the blood pressure to drop. Cardizem Unotard prolonged-release tablets contain diltiazem in a core surrounded by a small hole. The tablet shell passes unaffected through the intestine, while the active substance is released during the passage through the gastrointestinal tract.

Treatment of high blood pressure ( hypertension ) and angina in the heart (stable angina pectoris ).

2. What you need to know before using Cardizem Unotard

Do not use Cardizem Unotard

  • If you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer from severe heart problems (eg certain types of heart block, acute myocardial infarction, heart failure, or heart rhythm disorders).
  • If you suffer from digitalis poisoning.
  • If you are already taking a medicine containing ivabradine to treat certain heart conditions.

Warnings and cautions

Talk to your doctor or pharmacist before using Cardizem Unotard.

If you have any of the following conditions, you should consult a doctor before starting treatment with Cardizem Unotard:

  • low blood pressure
  • narrowing of the great carotid artery
  • any heart disease that affects the rhythm of the heart
  • impaired renal or hepatic function
  • risk of developing intestinal obstruction (intestinal obstruction).

Calcium antagonists such as diltiazem may cause mood swings, including depression.

Stop taking Cardizem Unotard and contact your doctor immediately if you get any of the following symptoms ( angioedema )

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

Other medicines and Cardizem Unotard

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines can affect or be affected by treatment with Cardizem Unotard, e.g. certain medicines:

  • for high blood pressure (nifedipine, beta-blockers, alpha-blockers, and calcium channel blockers )
  • for high blood pressure and angina (amlodipine)
  • against angina (nitrate derivatives)
  • against heart rhythm disorders (eg amiodarone )
  • lipid-lowering drugs ( simvastatin )
  • against epilepsy (carbamazepine)
  • with sedative and hypnotic effect (midazolam, triazolam)
  • against anxiety and depression (buspirone, imipramine)
  • against pain during surgery (alfentanil)
  • in transplantation (cyclosporine)
  • against manic-depressive illness (lithium)
  • drugs which inhibit the formation of hydrochloric acid and which are used against e.g. gastric ulcer (ranitidine, cimetidine)
  • against tuberculosis (rifampicin)
  • against inflammatory diseases such as rheumatism, ulcerative colitis, and asthma(methylprednisolone)
  • drugs that suppress the immune system (sirolimus, temsirolimus, and everolimus).

The treating physician, therefore, needs to be aware of such concomitant medication. If you need anesthesia during an operation, tell the anesthetist that you are taking Cardizem Unotard.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Cardizem Unotard during pregnancy.

It is possible that a breastfed baby may be affected. Therefore, do not use Cardizem Unotard during breast-feeding unless specifically prescribed by a doctor.

Driving and using machines

During treatment with Cardizem Unotard, side effects such as dizziness and malaise may occur. This should be taken into account when sharper attention is required, e.g. while driving or precision work.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cardizem Unotard contains sucrose and sodium

Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) sodium per prolonged-release tablet, ie is essential ‘sodium-free’.

3. How to use Cardizem Unotard

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor who adjusts it individually for you.

Cardizem Unotard prolonged-release tablets should be taken once daily and swallowed whole with at least ½ glass of liquid 15 minutes before a meal at approximately the same time each day. The tablets must not be divided or chewed.

If you forget to use Cardizem Unotard

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Cardizem Unotard and contact your doctor immediately if you get any of the following symptoms:

  • swelling of the face, tongue, or throat, difficulty swallowing, hives and difficulty breathing ( angioedema ). May affect up to 1 in 1,000 users.
  • an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals ( Stevens-Johnson syndrome ). May affect up to 1 in 1,000 users.
  • severe skin damage (skin peeling and superficial mucosa) ( toxic epidermal necrolysis ). May affect up to 1 in 1,000 users.

Very common (may affect more than 1 user in 10):

  • fluid retention, swelling of the arms and legs (peripheral edema )

Common (may affect up to 1 in 10 people):

  • headache
  • dizziness
  • fatigue
  • heart block ( AV block I, II, or III)
  • herds
  • nausea
  • constipation
  • heartburn and acid reflux ( dyspepsia )
  • abdominal pain
  • rash
  • itching
  • feeling sick
  • flushing with a feeling of warmth
  • palpitation
  • liver effects

Uncommon (may affect up to 1 in 100 people):

  • nervousness
  • difficulty falling asleep
  • low heart rate
  • a sudden drop in blood pressure when getting up
  • vomiting
  • diarrhea
  • increased liver values ​​( AST, ALT, LDH, or ALP)

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

  • heart rhythm disorders (such as fast heart rate, extra beats)
  • aggravated angina
  • low blood pressure
  • dry mouth
  • hives
  • ankle swelling
  • muscle and joint pain
  • skin and mucosal disorders (sometimes severe)
  • sleep disorders
  • confusion
  • hepatitis

Has been reported (occurs in an unknown number of users):

  • decreased platelet count in the blood
  • mood swings (including depression)
  • involuntary muscle movements (extrapyramidal syndrome)
  • short, involuntary muscle twitching (myoclonus)
  • heart failure
  • inflammation of a vessel wall ( vasculitis )
  • gum swelling
  • photosensitivity ( photosensitivity )
  • rash
  • scaly inflammation (exfoliative dermatitis )
  • blisters on the body ( pustulosis )
  • sometimes scaly redness with or without fever (desquamative erythema )
  • sweating
  • enlargement of the mammary glands.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Cardizem Unotard

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is Diltiazem hydrochloride 180 mg, 240 mg, and 300 mg respectively per tablet.

The other ingredients are Sodium dihydrogen citrate, sucrose (33 mg, 38 mg, and 38 mg per tablet respectively), povidone, magnesium stearate, macrogol, acetyl tributyl citrate, polymerized castor oil, sodium bicarbonate, ethylvanillin, titanium dioxide (dye coating E171).

What the medicine looks like and the contents of the pack

Appearance:

180 mg and 240 mg prolonged-release tablets are white, cupped and oval.

300 mg prolonged-release tablets are white, cupped and round.

Pack sizes:

Cardizem Unotard 180 mg prolonged-release tablet is

HDPE jar with a child-resistant lid in polypropylene (PP) containing 30 and 100 tablets respectively.

Cardizem Unotard 240 mg prolonged-release tablet is

HDPE jar with a child-resistant lid in polypropylene (PP) containing 30 and 100 tablets respectively.

Cardizem Unotard 300 mg prolonged-release tablet is

HDPE jar with a child-resistant lid in polypropylene (PP) containing 100 tablets.

The jar with the child-resistant lid is opened by holding the lid down and screwing it counterclockwise.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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