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Consumer Medication Information Leaflet (RiMUP)

DESOLON TABLET
Desogestrel/ Ethinylestradiol (0.15mg/0.03mg)

What is in this leaflet • Heavy smoking (15 cigarettes/day) • Anticoagulants (to prevent blood
1. What Desolon is used for in individuals >35 years of age clot)
2. How Desolon works • History of blood clots or blood • Anticonvulsants (eg:
3. Before you use Desolon clotting problems (such as stroke, carbamazepine, felbamate,
4. How to use Desolon heart attack). phenobarbital, phenytoin,
5. While you are using it Do not use Desolon if you have Hepatitis topiramate)
6. Side effects C and are taking the medicinal products • Vitamin C
7. Storage and Disposal of Desolon containing ombitasvir/ paritaprevir/ • Atorvastatin (for cholesterol)
8. Product Description ritonavir and dasabuvir. • Benzodiazepine (eg: alprazolam,
9. Manufacturer and Product chlordiazeposide, diazepam,
Registration Holder Pregnancy and lactation lorazepam, oxazepam, temazepam
10. Date of revision Do not take Desolon if you are pregnant, which used as sleeping pill)
trying to get pregnant or think you may • Clofibric acid (for cholesterol)
What Desolon is used for be pregnant. • Cyclosporine (used in organ
Desolon is an estrogen and progestin transplant rejection)
combination pill used for the prevention Do not take Desolon if you are breast- • Griseofulvin (antifungal)
of pregnancy. feeding. Ask your doctor or pharmacist • Morphine (pain killer)
for advice before taking any medicine. • Antiviral medicines (eg: nevirapine,
How Desolon works amprenavir, lopinavir, nelfinavir,
Combined oral contraceptives like - Before you start to use it ritonavir)
Desolon Tablet work mainly by tricking Tell your doctor or pharmacist if you • Prednisolone (steroid)
your body into thinking that ovulation have any of these other conditions, you • Repaglinide, troglitazone (for
has already happened. This prevents an may need a dose adjustment or special diabetes)
egg from ripening and being released tests to safely take Desolon Tablet: • Salicylic acid (for pain killer)
from the ovaries each month. • blood clot events • Selegiline (for Parkinson disease)
The hormones also increase the thickness • Liver function test is abnormal • Theophylline (for respiratory
of the natural mucus at the neck of the • Varicose veins (swollen and disorder)
womb, which makes it more difficult for enlarged veins) • Tricyclic antidepressant (eg:
sperm to cross from the vagina into the • Chloasma (facial pigmentation) amitriptyline, imipramine,
womb and reach an egg. They also • Depression nortriptyline)
change the quality of the womb lining • You are taking any steroids • Certain food (eg: caffeine,
(endometrium), making it less likely that • Heart failure grapefruit juice)
a fertilised egg can implant there. • Kidney problem • Herbs/supplements (eg: St John’s
• High Blood Pressure wort, dong guai, black cohosh, saw
Before you use Desolon • Epilepsy palmetto, red clover, ginseng)
- When you must not use it • Migraine
Do not use this medication if you are • Gynaecological problem that is Do not use Desolon if you have Hepatitis
allergic to any of the ingredients of sensitive to estrogen (eg: tumor in C and are taking the medicinal products
Desolon Tablet or are pregnant. Tell your uterus, cells growth outside the containing ombitasvir/ paritaprevir/
doctor right away if you become uterus) ritonavir and dasabuvir. Your doctor will
pregnant during treatment. You should • Abdominal mass and/or with prescribe another type of contraceptive
not use this medicine if you have: abdominal pain before starting the treatment with these
• Unexplained vaginal bleeding • Infection medicinal products.
• History or suspected cancer that
may grow under the influence of - Taking other medicines How to use Desolon
sex hormones (breast, Tell your doctor if you are taking any - How much to use
endometrium) other medicines, including any that Follow all directions given to you by
• Liver disease or tumor you buy without a prescription from a your doctor and pharmacist carefully.
• History of disorder affecting the pharmacy, supermarket or health food They may differ from the information
blood circulation. shop. contained in this leaflet. If you do not
• Severe high blood pressure • Acetaminophen (for pain killer or understand the instructions on the label,
• Diabetes with blood vessel damage fever) ask your doctor or pharmacist for help.
• Severe headache with impairments • Acitretin (for psoriasis)
of nerve, spinal cord, or brain • Aminoglutethimide (antisteroid One tablet is taken every day for 21 days
function medicine) followed by a seven day break from pill-
• Major surgery with prolonged • Antibiotics (eg: ampicillin, taking. Each subsequent pack is started
inability to move around tetracycline, rifampin)

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Consumer Medication Information Leaflet (RiMUP)

after the 7-day tablet-free period has Tell all the doctors, dentists and • weight gain or loss
elapsed. pharmacists treating you that you are • yellowing of the skin and white of
taking Desolon. the eyes
- When to use it • infection in vaginal
The first tablet of the first pack is taken Tell your doctor immediately if you • benign liver tumours
on the first day of menstruation. This become pregnant while taking this • cataract, intolerance to contact lens
also applied when changing over from medication. • impaired kidney function
another brand of oral contraceptive.
- Things you must not do You may report any side effects or
After delivery administration can be Do not stop taking the medicine unless adverse drug reactions directly to the
started on the first day of the first advised by your doctor. National Centre for Adverse Drug
spontaneous menstruation. If it is Reaction Monitoring by calling Tel: 03-
necessary to start earlier, eg. immediately Do not take any new medicines without 78835550, or visiting the website
after delivery, additional contraceptive consulting your doctor or pharmacist. npra.moh.gov.my (Public Reporting
precautions are necessary for the first 14 Side Effects to Medicines (ConSERF) or
days of tablet intake. Do not give Desolon to anyone else, Vaccines (AEFI)
even if they have the same symptoms or
After a miscarriage or abortion condition as you. Storage and Disposal of Desolon
administration should start immediately. - Storage
In this way no additional contraceptive - Things to be careful of Keep out of the reach and sight of
precautions are required. Driving and using machines children.
If the tablets make you feel sick, dizzy or
- How long to use it tired, or give you a headache, do not Store in a cool place (below 30°C),
Continue taking Desolon for as long as drive or use machines and contact your protected from light.
your doctor recommends. doctor immediately.
- Disposal
- If you forget to use it Side effects Medicines should not be disposed of
Consult your doctor or pharmacist on Like all medicines, Desolon can cause via wastewater or household waste.
what you should do if you forget to use side effects, although not everybody gets Ask your pharmacist how to dispose of
it. them. medicines no longer required. These
measures will help to protect the
Take the missed dose as soon as you Visit your doctor or pharmacist environment.
remember. If it is almost time for your immediately if you experience any side
next dose, wait until then to take the effects after taking this medicine. Product Description
medicine and skip the missed dose. Do - What it looks like
not take a double dose to make up for the Desolon may cause: Each tablet is smooth well-formed
missed dose. • blood clot, stroke, high blood white round biconcave with upper
pressure, heart attack, edema punch logo and lower punch plain, free
- If you use too much (overdose) (swelling) from chips, spots and foreign particles
Contact your doctor immediately or go to • depression, dizziness, headache,
the Emergency Department of your migraine, nervousness, premenstrual - Ingredients
nearest hospital, if you think you or syndrome - Active ingredients
anyone else may have taken too much of • acne Desogestrel 0.15mg and
this medicine. Do this even if there are • brown, blotchy spots on exposed skin Ethinylestradiol 0.03mg.
no signs of discomfort or poisoning. You • rash
may need urgent medical attention. • gain of body hair or loss of facial hair - Inactive ingredients
• No menstrual, breakthrough bleeding, Colloidal silicon dioxide,
There have been no reports of serious spotting or change in menstrual flow. pregelatinised maize starch, Maize
deleterious effects from overdose. • breast enlargement, tenderness, or starch, lactose monohydrate, polyvinyl
Symptoms that may occur in this case secretion pyrrolidone, stearic acid, DL-α-
are: nausea, vomiting and possible slight • increased or decreased interest in Tocopherol, acetone, methylene
vaginal bleeding in young girls. sexual intercourse chloride.
• decrease milk supply
While you are using it • Increase sex hormones - MAL number:
- Things you must do • temporary infertility MAL10070585AZ
Take your medicine exactly as your • intolerance to carbohydrate
doctor has told you. • Increase triglycerides
• abdominal cramping or bloating,
change in appetite, nausea, vomiting

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Consumer Medication Information Leaflet (RiMUP)

Manufacturer
Renata Limited
Section 7,
Milk Vita Road, Mirpur,
Dhaka, Bangladesh

Product Registration Holder


Vitamode Sdn Bhd
55, Lorong Sempadan 2,
(Off Boundary Road), 11400 Ayer Itam,
Penang, Malaysia.

Date of revision
23.5.2018

Serial number
NPRA(R4/1) 140318/00067

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