Patient Medication Information: uses, side effects, how to take - Pal-Pravastatin-ASA
What the medication is used for:
What the medication is used for:
Pal-Pravastatin-ASA is indicated for the patients for whom treatment with both pal-Pravastatin and pal-ASA EC at the same time is appropriate. As the two medications are co-packaged in a compliance pack, you may find Pal-Pravastatin-ASA more convenient to use.
Your doctor may prescribe a program of weight control, smoking cessation, physical exercise and/or a cholesterol-lowering diet for you while you are taking Pal-Pravastatin-ASA. Do follow your doctor’s instructions.
What it does:
Pal-Pravastatin-ASA may help people who have one or more of these problems:
- a heart attack in the past
chest pain from heart problems (also called
angina)
a bypass operation or angioplasty to open
the blood vessels of the heart
blood flow problems to the brain (such as
strokes, near-strokes, or mini-strokes)
Pal-Pravastatin-ASA contains 2 medicines taken together.
pal-ASA EC stops part of the normal blood clotting process and so keeps clots or plugs from forming in your blood vessels. pal-ASA EC contains
acetylsalicylic acid delayed-release and other ingredients that may lower your chance of getting an upset stomach.
pal-Pravastatin lowers your “bad” LDL cholesterol and raises your “good” HDL cholesterol. High cholesterol can lead to plugs or clots in your blood vessels.
When it should not be used:
Do not take Pal-Pravastatin-ASA if:
you are allergic to any of the ingredients in
Pal-Pravastatin-ASA.
- you are allergic to or have had breathing difficulties after using any medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs) including acetylsalicylic acid and other salicylates;
- you have an active liver disease, or unexplained, persistent elevations in liver function values (transaminases) in your blood test results;
- you have kidney problems;
- you have an active peptic ulcer;
- if you are pregnant, planning to become pregnant or breast-feeding;
- you are 18 years of age or younger.
What the medicinal ingredients are:
The active ingredient in pal-ASA EC is acetylsalicylic acid. The active ingredient in pal-Pravastatin is pravastatin sodium.
What the important non-medicinal ingredients are:
pal-Pravastatin, 10 mg, 20 mg and 40 mg.
Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate, Lactose Monohydrate Spray Dried, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol and Pyrrolidone/Vinyl Acetate Copolymer. Available in blister packs of 10 tablets.
ABOUT THIS MEDICATION
pal-Pravastatin 10 mg: Iron Oxide IC07470 Red #30;
pal-Pravastatin 20 mg: Iron Oxide IC07434 Yellow #10;
pal-Pravastatin 40 mg: Lake Blend Green LB-451.
81 mg: Colloidal anhydrous silica, lactose anhydrous, methacrylic acid copolymer type C, methylated silica, methylcellulose, polyethylene glycol sorbitan tristearate, polydimethylsiloxane, pregelatinized starch, purified water, sodium bicarbonate, sodium lauryl sulphate, stearic acid, talc, titanium dioxide, triethyl citrate.
162 mg: Carnauba wax, colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose anhydrous, methylated silica, methylcellulose, polydextrose, polydimethylsiloxane, polyethylene glycol, plyvinyl aetate phthalate, pregelatinized starch , purified water, sodium alginate sodium bicarbonate, stearic acid triple presse powder, sureteric white, talc, titanium dioxide, triethyl citrate .
325 mg: Colloidal anhydrous silica, corn starch, guar gum, hydrogenated vegetable oil type I, iron oxide yellow, lecithin, methacrylic acid copolymer type C, methylated silica, methylcellulose, microcrystalline cellulose, polyethylene glycol sorbitan tristearate, polydimethylsiloxane, polyvinyl alcohol, sodium bicarbonate, sodium lauryl sulphate, talc, titanium dioxide, triethyl citrate, water.
What dosage forms it comes in:
Pal-Pravastatin-ASA contains one dosage strength of pal-Pravastatin (10 mg, 20 mg or 40 mg tablets) with one dosage strength of pal-ASA EC (81 mg, 162 mg tablets or 325 mg caplets). They are co-packaged in a compliance pack.
Pregnancy or breast feeding:
Pal-Pravastatin-ASA should not be used during pregnancy. Cholesterol is essential for the development of a baby. Cholesterol-lowering drugs can harm the baby. If you become pregnant while using Pal-Pravastatin-ASA, stop using the medication immediately and contact your doctor.
Pal-Pravastatin-ASA should not be used during breast feeding or if you intend to breast-feed. Pal-Pravastatin-ASA can pass into your breast milk and may harm your baby. You may need to choose between breast feeding or taking Pal-Pravastatin-ASA.
Before you use Pal-Pravastatin-ASA, talk to your doctor or pharmacist if you:
- have kidney problems
- have thyroid problems
- have bleeding problems
- have diabetes
- have severe anemia
- do excessive physical exercise
- have unexplained muscle aches or weakness, or if any occur during treatment
- have had any past problems with muscles (pain, tenderness) after using a statin
- have a personal or family history of muscular disorders
- have stomach problems such as heartburn, upset stomach, stomach pain or ulcers
- regularly drink 3 or more alcoholic drinks every day
- have asthma (wheezing) along with nasal polyps (small growths in your nose)
- are younger than 18 years; then you should not use any product with acetylsalicylic acid in it. Children can get a rare but very serious medical problem called Reye’s Syndrome if they take acetylsalicylic acid when they are sick.
- have decreased liver function or active liver disease;
- are elderly.
Tell your doctor about all the medicines you take, including other medicines that contain acetylsalicylic acid, prescription and non-prescription medicines, vitamin, and herbal supplements, as drug interactions are possible. You should also tell any physician who is prescribing a new medication for you that you are taking Pal-Pravastatin-ASA. Some medicines such as those listed below, can cause serious side effects if you take them while you are taking Pal-Pravastatin-ASA®. Be extra sure to tell your doctor if you take any of the following kinds of medicines: WARNINGS AND PRECAUTIONS
INTERACTIONS WITH THIS MEDICATION
blood thinners. Blood thinners can increase
your chance of bleeding since the
acetylsalicylic acid in Pal-Pravastatin-ASA also blocks normal blood clotting.
certain medicines for high cholesterol or high
triglycerides called fibrates (gemfibrozil, fenofibrate) or niacin.
medicines to reduce serum cholesterol
(“statins”) such as atorvastatin (Lipitor®), fluvastatin (Lescol®), Lovastatin (Mevacor®), pravastatin (Pravachol®), rosuvastatin (Crestor®) or simvastatin (Zocor®);
large doses (more than 1 g/day) of niacin
(nicotinic acid) (drug to lower cholesterol).
Pal-Pravastatin-ASA may affect how some of your other medicines work. If you take a high blood pressure medicine called an ACE inhibitor, you may need to have your blood pressure checked more often.
It is also important to tell your doctor if you are taking antacid, corticosteroids, methotrexate, anticoagulants (drug that prevents blood clots, such as warfarin), digoxin (a drug used to treat heart problems), ketoconazole, spironolactone, or cimetidine, or analgesic-antipyretic agents such as acetaminophen.
Pal-Pravastatin-ASA is not for initial therapy. The individual dosage of both medications within Pal-Pravastatin-ASA must be stabilized for you by your physician, before your doctor can switch you to Pal-Pravastatin-ASA.
Usual dose:
pal-Pravastatin: The recommended starting dose of pal-Pravastatin is 10 to 20 mg once daily. If the cholesterol in your blood is markedly elevated, your doctor may start you on a 40 mg/day dose.
pal-ASA EC: 1 tablet daily of 81 mg, 162 mg or 325 mg caplet as directed by your physician. Do not take more than your physician recommends. pal-ASA EC tablets have a special enteric coating designed to help prevent stomach upset. To benefit from this protection, the tablets must be swallowed whole and should not be crushed or broken.
The usual dose of Pal-Pravastatin-ASA is one pal-ASA EC (acetylsalicylic acid delayed release) tablet/caplet with one pal-Pravastatin (pravastatin) tablet once a day, at bedtime. Pal-Pravastatin-ASA comes in different strengths and your doctor may adjust your dose. Do not change your dose without talking to your doctor.
You need to follow your doctor’s advice and take Pal-Pravastatin-ASA every day in order for it to lower your chances of dying from heart disease, having a heart attack, or having a stroke. If you stop taking Pal-Pravastatin-ASA, it will not help you anymore. You must tell your doctor if you stop taking Pal-Pravastatin-ASA.
- Take Pal-Pravastatin-ASA exactly as your doctor prescribes it.
You can take Pal-Pravastatin-ASA with or without food.
- Take Pal-Pravastatin-ASA with a full glass of water, unless your doctor has told you to keep your fluids low.
- Your doctor will monitor your condition and have blood tests done at regular intervals. Please keep your appointments.
- Avoid excessive alcohol intake.
- Tell your doctor of any new illnesses which occur during treatment.
Some people may need to stop taking Pal-
Pravastatin-ASA completely or for a long time. Call your doctor if you plan to have any surgery, medical, or dental procedures. You may be told to stop taking Pal-Pravastatin-ASA for a while to lower your risk of bleeding.
How to use a compliance pack:
Your tablets come in press-through compliant sleeves. Your compliance pack contains 3 sleeves for a total of 30 days of therapy. Each sleeve includes 10 tablets of pal-simvastatin and 10 tablets of pal-ASA EC. Take one tablet from the orange panel and one tablet from the teal panel every day until you complete all 3 sleeves.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
PROPER USE OF THIS MEDICATION
If you miss a dose, take it as soon as you remember. Do not take 2 doses in the same day.
Pal-Pravastatin-ASA can cause unwanted side effects. Possible side effects reported with some statins: breathing problems including persistent cough and/or shortness of breath or fever.
The following adverse events have been reported with some statins: Sleep Disturbances, including insomnia and nightmares. Mood related disorders including depression. Erectile dysfunction.
Check with your doctor or pharmacist promptly if any of the following persist or become troublesome:
- heartburn
- hoarseness
Call your doctor if you experience loss of hearing, including ringing or buzzing in the ears.
There is a risk of muscle breakdown for patients taking Pal-Pravastatin-ASA. The risk is greater if you are taking higher doses of Pal-Pravastatin-ASA and if you have abnormal kidney function.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||||
If effect persists or becomes bothersome | In all cases | |||||
Aching muscles, muscle cramps, unexplained mucle pain, tenderness, cramping, aching or weakness, rhabdomyolysis (a muscle wasting disease), associated muscle tenderness | √ | |||||
| Tiredness/weak ness, dizziness, fainting spells | √ | |||||
| Fever | √ | |||||
| Blurred vision | √ | |||||
Constipation, diarrhea, gas, stomach upset, nausea, loss of appetite, vomiting | √ | |||
| Pain in the abdomen/upper part of stomach | √ | |||
| Headache | √ | |||
| Skin rash, hives, itching | √ | |||
Flushing, swelling, joint pain, fever, light sensitivity | √ | |||
| Black stools | √ | |||
| Stomach irritation | √ | |||
Unusual bleeding or bruising | √ | |||
Brownish or discoloured urine | √ | |||
| Liver damage: yellowing of the skin or eyes, flu-like symptoms | √ | |||
Allergic reactions: difficulty breathing or swallowing, swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs | √ |
These are not all the possible side effects of Pal-Pravastatin-ASA. If other effects occur, they generally do not require medical attention, and may come and go during treatment. If any persist or become troublesome, do check with your physician or pharmacist.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
REPORTING SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance.
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to : Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
Do not use outdated medicine.
Pal-Pravastatin-ASA is provided in a press-through compliant blister package suitable for direct distribution to the patient. Store Pal-Pravastatin-ASA in the provided package. Protect from moisture and light.
- Keep all medicines out of the reach of children.
Store your tablets at room temperature (15-30 ºC).
This document plus the full product monograph prepared for health professionals can be obtained by contacting:
By mail:
Paladin Labs Inc.
6111 Royalmount Ave., Suite 102
Montreal, Quebec
H4P 2T4
By telephone: 1-888-550-6060 http://www.paladinlabs.com