Patient leaflet - LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE 100 MG / 12.5 MG FILM-COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT
/…/ 100 mg/25 mg film-coated tablets
Losartan potassium/hydrochlorothiazide
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each /…/ 50 mg/12.5 mg tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Each /./ 100 mg/12.5 mg tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Each /./ 100 mg/25 mg tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
3. LIST OF EXCIPIENTS
4. PHARMACEUTICAL FORM AND CONTENTS
Film-coated tablets [Blister:]
10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 film-coated tablets [For 50 mg/12.5 mg and 100 mg/25 mg film-coated tablets only :]
[Container:]
100, 250 or 500 film-coated tablets [For 100 mg/12.5 mg film-coated tablets only :]
[Container:]
100 or 300 film-coated tablets
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use. Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
[For 100 mg/12.5 mg film-coated tablets only :]
[Container:]
Shelf life after opening: 6 months
9. SPECIAL STORAGE CONDITIONS
[Blister:]
Store below 25°C.
[Tablet container:] Store below 30°C.
[For 100 mg/12.5 mg film-coated tablets only :]
Store below 30°C and store in the original packaging in order to protect from moisture.
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
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12. MARKETING AUTHORISATION NUMBER(S)
GENERAL CLASSIFICATION FOR SUPPLY
<Medicinal product subject to medical prescription.>
16. INFORMATION IN BRAILLE
/…/ 100 mg/25 mg
17. UNIQUE IDENTIFIER - 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC:
SN:
NN:
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blister
| 1. NAME OF THE MEDICINAL PRODUCT
/…/ 50 mg/12.5 mg film-coated tablets /…/ 100 mg/12.5 mg film-coated tablets
/…/ 100 mg/25 mg film-coated tablets
Losartan potassium/hydrochlorothiazide
2. NAME OF THE MARKETING AUTHORISATION HOLDER
<[To be completed nationally]>
{Name}
| 4. BATCH NUMBER
Lot
| 5. OTHER ~
The drug is classified in the ATC tree:
Frequently Asked Questions
What is Losartan Potassium/Hydrochlorothiazide used for?
Losartan Potassium/Hydrochlorothiazide is commonly prescribed to treat high blood pressure (hypertension) and to help protect your kidneys if you have diabetes.
How does Losartan Potassium/Hydrochlorothiazide work?
This medication combines an angiotensin receptor blocker (Losartan) and a diuretic (Hydrochlorothiazide) to help lower blood pressure by relaxing blood vessels and removing excess fluid from the body.
What should I do if I miss a dose of Losartan Potassium/Hydrochlorothiazide?
If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double up.
Can I take Losartan Potassium/Hydrochlorothiazide during pregnancy?
It’s important to talk to your doctor before taking this medication during pregnancy as it may harm the unborn baby, especially in the second and third trimesters.
Are there any foods or drinks I should avoid while taking this medicine?
Avoid excessive amounts of potassium-rich foods or supplements since Losartan can increase potassium levels in the body. Alcohol should also be consumed in moderation.
What are the side effects of Losartan Potassium/Hydrochlorothiazide?
Common side effects may include dizziness, headache, fatigue, and increased urination. If you experience severe side effects like fainting or allergic reactions, seek medical help immediately.
How long does it take for Losartan Potassium/Hydrochlorothiazide to work?
You may start to notice lower blood pressure within a few hours of taking the first dose, but it can take several weeks for full benefits.
Can I stop taking Losartan Potassium/Hydrochlorothiazide suddenly?
No, you should not stop this medication abruptly without consulting your doctor, as it may cause your blood pressure to rise again.
Is Losartan Potassium/Hydrochlorothiazide suitable for elderly patients?
Yes, but elderly patients may need careful monitoring for side effects and dosage adjustments due to potential kidney issues.
Can I take other medications with Losartan Potassium/Hydrochlorothiazide?
Always inform your doctor about any other medications or supplements you are taking, as some can interact with this medication.
What should I do if I experience severe dizziness while taking this medication?
If you experience severe dizziness or lightheadedness, sit or lie down until it passes. If symptoms persist or worsen, contact your healthcare provider.
Can Losartan Potassium/Hydrochlorothiazide affect my kidney function?
Yes, this medication can affect kidney function. Regular blood tests may be needed to monitor your kidneys while on this medication.
Is weight gain a common side effect of Losartan Potassium/Hydrochlorothiazide?
Weight gain is not a common side effect; however, if you notice sudden weight gain or swelling in your feet or legs, contact your doctor.
Should I avoid sunlight while taking this medication?
Hydrochlorothiazide can make you more sensitive to sun exposure. It’s advisable to use sun protection when outdoors.
Can I exercise while taking Losartan Potassium/Hydrochlorothiazide?
Yes, regular exercise is encouraged as part of managing high blood pressure; just consult your doctor before starting any new exercise regimen.
What lab tests will I need while on this medication?
Your doctor may require regular blood tests to monitor kidney function and electrolyte levels while you are taking Losartan Potassium/Hydrochlorothiazide.
What should I do in case of an overdose?
In case of an overdose, seek emergency medical attention immediately. Symptoms may include low blood pressure and increased heart rate.
How should I store Losartan Potassium/Hydrochlorothiazide tablets?
Store the tablets at room temperature away from light and moisture, and keep them out of reach of children.
Is it safe to drive after taking Losartan Potassium/Hydrochlorothiazide?
While many patients can drive safely after taking this medication, if you experience dizziness or fatigue, it's best to avoid driving until you know how it affects you.
