Details for: SANDOZ DILTIAZEM CD
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243338 | SANDOZ DILTIAZEM CD | DILTIAZEM HYDROCHLORIDE | 120 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02243339 | SANDOZ DILTIAZEM CD | DILTIAZEM HYDROCHLORIDE | 180 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02243340 | SANDOZ DILTIAZEM CD | DILTIAZEM HYDROCHLORIDE | 240 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
| 02243341 | SANDOZ DILTIAZEM CD | DILTIAZEM HYDROCHLORIDE | 300 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Sandoz Diltiazem CD is used for:
- the management of effort associated angina (chest pain)
- the treatment of mild to moderate high blood pressure.
Sandoz Diltiazem CD should normally be used in those patients in whom treatment with other blood pressure reduction medications has been ineffective, or have been associated with unacceptable side effects.
What it does
Sandoz Diltiazem CD belongs to the group of drugs called “calcium channel blockers” or “calcium antagonists”. Sandoz Diltiazem CD relaxes the arteries, thereby lowering blood pressure.
Sandoz Diltiazem CD reduces the amount of oxygen that your heart muscle needs. This helps control chest pain.
When it should not be used
Do not use Sandoz Diltiazem CD if:
- You are pregnant or plan to become pregnant.
- You are breastfeeding.
- You have a known allergy to diltiazem or to any of the non-medicinal ingredients.
- You have very low blood pressure (< 90 mmHg systolic).
- You have heart rhythm disorders in the absence of a pacemaker.
- You have severe heart failure with fluid in the lungs.
- You are taking a medicine called dantrolene used for severe muscle spasms or severe fever.
- You are using ivabradine
What the medicinal ingredient is
Diltiazem Hydrochloride
What the non-medicinal ingredients are
Acetyl tributyl citrate, ethylcellulose, magnesium stearate, methylacrylic acid copolymer Type B, polysorbate, sugar spheres and talc. The gelatin capsules contain: black iron oxide (300 mg only), FD&C blue #1, gelatin and titanium dioxide.
What dosage form it comes in
Capsules: 120 mg, 180 mg, 240 mg, and 300 mg.
Warnings and precautions
BEFORE you use Sandoz Diltiazem CD talk to your doctor or pharmacist if:
- You have very low blood pressure.
- You have ever had a bad or unusual reaction to any drug containing diltiazem in the past.
- You have heart, liver, or kidney disease.
- You have high blood sugar or diabetes.
- You are 65 years or older.
- You have a history of heart failure, new shortness of breath, slow heartbeat or low blood pressure. Cases of kidney injury in patients with such conditions have been reported.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Additional monitoring of your dose or condition may be needed if you are taking other drugs.
The following may interact with Sandoz Diltiazem CD:
- Antifungal medications with a name ending in azole;
- Medications used to control the immune system such as cyclosporine;
- Certain antibiotics should not be taken with Sandoz Diltiazem CD such as erythromycin, rifampin. Check with your pharmacist if not sure;
- Sleeping pills such as benzodiazepines (midazolam, triazolam);
- Other blood pressure medications: alpha antagonists, beta-blockers;
- Heart medications: Amiodarone, digoxin, digitalis, flecainide, nifedipine, propafenone, quinidine, verapamil, ivabradine;
- Anaesthetics;
- Lithium and imipramine used for some types of mental illness;
- Drugs that dilate the blood vessels: short and long acting nitrates; Medications used to control seizures: carbamazepine, phenobarbital, phenytoin;
- Warfarin used as anticoagulant;
- Cholesterol lowering medications: statins;
- Theophylline used for breathing problems;
- Terfenadine or ranitidine used for allergies;
- Medications used to control stomach ulcers such as cimetidine will increase the effects of Sandoz Diltiazem CD;
- Multivitamins with minerals (calcium-containing products);
- Drugs to treat inflammation: corticosteroids, methylprednisolone;
- Dantrolene used for severe muscle spasms or severe fever.
- Acetylsalicylic acid (Aspirin) or antiplatelet drugs such as ticagrelor, cilostazol, clopidogrel, dipyridamole, ticlopidine.
- X-Ray contrast agents.
Alcohol may cause low blood pressure and dizziness when you go from lying or sitting to standing up. This can especially occur after the first dose and when the dose is increased. Tell your doctor if you experience dizziness, light-headedness, fainting, decreased blood pressure or increased heart rate.
Grapefruit juice when consumed too often while taking Sandoz Diltiazem CD may cause headache, irregular heartbeat, edema (swelling), unexplained weight gain, and chest pain. Tell your doctor if this happens to you. Your doctor may recommend that grapefruit juice be avoided if this happens to you.
Proper use of this medication
- Do not miss doses or take extra doses, unless your doctor tells you. If you are not clear about the directions, ask your doctor or pharmacist.
Take Sandoz Diltiazem CD exactly as your doctor tells you.
- Sandoz Diltiazem CD is taken once a day
- Dosage should be individualised.
Swallow capsules whole. DO NOT chew or crush Sandoz Diltiazem CD capsules.
Usual Adult Dose
Angina
- Starting dose: 120 mg to 180 mg once a day.
Dose may be slowly (over 7 to 14 days) increased up to 360
mg a day. Always follow your doctor’s instructions.
High blood pressure
- Usual starting doses: 180 to 240 mg once a day.
120 mg a day may be used in some patients.
Maximum dose: 360 mg a day.
Overdose
Missed Dose
If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
Side effects and what to do about them
Side effects may include:
- Headache, dizziness, malaise;
- Nausea (feeling like vomiting);
- Flushing (facial redness) or feeling unusually warm;
- Unusual tiredness and weakness;
- Upset stomach.
Sandoz Diltiazem CD can cause abnormal blood results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse or pharmacist only if severe | Talk with your doctor, surse or pharmacist in all cases | Stop taking drug and seek immediate medical help |
|---|---|---|---|
| Rare | |||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Common | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up. | ✔ | ||
| Fast, slow, or irregular heartbeat | ✔ | ||
| Peripheral edema: swelling of the ankles | ✔ | ||
| Respiratory tract infection: pharyngitis, rhinitis | ✔ | ||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Uncommon | |||
| Depression: low mood, lack of interest in usual activities, change in sleep and appetite. | ✔ | ||
| Heart block: A disease in the electrical system of the heart causing lightheadedness, fainting and irregular heartbeat. | ✔ | ||
| Heart Attack: shortness of breath, chest pain | ✔ | ||
| Angina: Chest pain | ✔ | ||
| Heart Failure: shortness of breath, leg swelling, and exercise intolerance. | ✔ | ||
| Eye Problems: decreased vision, irritation, sore red eyes | ✔ | ||
| Increased blood sugar: frequent urination, thirst, and hunger | ✔ | ||
| Unknown | |||
| Serious Skin Reactions (StevensJohnson Syndrome, Toxic Epidermal Necrolysis, hypersensitivity Syndrome): any combination of itchy skin rash, redness, blistering and peeling of the skin and /or of the lips, eyes, mouth, nasal passages or genitals, accompa-nied by fever, chills, headache, cough, body aches or joint pain, yellowing of the skin or eyes, dark urine. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Sandoz Diltiazem CD, contact your doctor or pharmacist.
How to store
Store in tight containers between 15 and 30°C. Protect from light. Keep out of sight and reach of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting(https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) or information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sandoz Canada Inc., at:
1-800-361-3062
or by written request at:
145 Jules-Léger
Boucherville QC
J4B 7K8
Or by e-mail at :
medinfo@sandoz.com
This leaflet was prepared by Sandoz Canada Inc
Last revised: September 18, 2019