12.5 mg and 25 mg tablets hydrochlorothiazide

1. What Hydrochlorothiazide Evolan is and what it is used for

Hydrochlorothiazide Evolan is a diuretic and antihypertensive drug. The decrease in blood pressure is partly due to the diuretic effect but probably also due to the dilation of certain blood vessels ( arterioles ).

Hydrochlorothiazide Evolan is used for high blood pressure and fluid retention in the body ( edema ).

Hydrochlorothiazide contained in Hydrochlorothiazide Evolan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2.What you need to know before you take Hydrochlorothiazide Evolan

Do not take Hydrochlorothiazide Evolan

  • if you are allergic to hydrochlorothiazide , other diuretics ( diuretics ) or any of the other ingredients of this medicine (listed in section 6).
  • if you have severe liver or kidney disease.
  • if you have gout .

Warnings and cautions

Talk to your doctor or pharmacist before taking Hydrochlorothiazide Evolan.

  • if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses , may increase the risk of certain types of skin and lip cancer (non- melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Hydrochlorothiazide Evolan
  • if you have diabetes .
  • if you have atherosclerosis of the heart or brain.
  • if you experience impaired vision or eye pain. This may be a symptom of fluid accumulation in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within a few hours to weeks after taking Hydrochlorothiazide Evolan. This can lead to permanent vision loss if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this

For long-term treatment with Hydrochlorothiazide Evolan, it is important that your diet contains enough potassium (consult your doctor).

Hydrochlorothiazide Evolan contains lactose

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

Other medicines and Hydrochlorothiazide Evolan

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

The treatment effect may be affected if this medicine is taken at the same time as certain other medicines. This applies in the first place

  • digitalis glycosides
  • sotalol (drugs that affect the heart rhythm)
  • non-steroidal anti-inflammatory / anti-rheumatic drugs ( NSAIDs ) (medicines for pain, inflammation and fever)
  • cholestipol and cholestyramine (medicines for high blood fats)
  • lithium (medicine for manic-depressive illness)
  • carbamazepine (drugs against epilepsy )
  • selective serotonin reuptake inhibitors ( SSRIs ) (antidepressants)

Your doctor, therefore, needs to be aware of such concomitant medication.

Pregnancy and breastfeeding

Contact your doctor if you are pregnant or think you may be pregnant. Your doctor will usually suggest that you take another medicine instead of Hydrochlorothiazide Evolan as Hydrochlorothiazide Evolan is not recommended during pregnancy. This is because Hydrochlorothiazide Evolan passes into the fetus and can cause harm to the fetus and the newborn baby if used during the last 6 months of pregnancy.

Tell your doctor if you are breastfeeding or intend to start breastfeeding. Hydrochlorothiazide Evolan is not recommended for women who are breastfeeding.

Driving and using machines

During treatment with Hydrochlorothiazide Evolan, the ability to react may be reduced, especially at the beginning of treatment. This should be taken into account when sharper attention is required, eg when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.

3. How to take Hydrochlorothiazide Evolan

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

Dose one is conveniently taken in the morning due to the diuretic effect.
The increased urine excretion begins about 2 hours after ingestion, is greatest after about 4 hours, and lasts about 12 hours.

High blood pressure The
recommended daily dose for adults is 12.5-50 mg daily.

Edema The
recommended daily dose for adults is 25-50 mg, in more severe cases 75-100 mg daily.

If you take more Hydrochlorothiazide Evolan than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. Possible side effects

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

Hydrochlorothiazide Evolan can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then inform about your medication.

In rare cases, Hydrochlorothiazide Evolan may cause severe hypersensitivity reactions (anaphylactic shock ) which may cause hives, swelling of the face, lips, mouth, tongue, or throat, or difficulty breathing. If you experience any of these, stop taking Hydrochlorothiazide Evolan immediately and contact a doctor or go to the nearest emergency room.

Other possible side effects:

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

  • Weakness, dizziness, headache
  • Fatigue
  • Potassium deficiency, elevated uric acid levels in the blood (possibly with gout problems), elevated blood sugar levels and elevated levels of blood fats (at high doses ).

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

  • Dizziness when getting up quickly,
  • Irregular heartbeat
  • Anorexia , nausea, vomiting, colic , diarrhea, constipation
  • Skin rash, hives , increased sensitivity to sunlight
  • Disturbances in the salt balance and acid-base balance.

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

  • Fever
  • Impotence
  • Anemia ( anemia ), lack of white blood cells ( leukopenia ), a shortage of blood platelets ( thrombocytopenia )
  • Emotional disorders, sleep disorders
  • Depression
  • Vascular inflammation ( vasculitis ), small bleeding points inside the skin, local dermatitis
  • Hepatitis, pancreatitis, effects on liver function
  • Pneumonia , fluid accumulation in the alveoli
  • Impact on renal function
  • Dimsyn.

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

  • Skin and lip cancer (Non- melanoma skin cancer)
  • Decreased vision or pain in the eyes due to high pressure (possible signs of fluid accumulation in the eye (between the choroid and retina) or acute narrow-angle glaucoma ).

5. How to store Hydrochlorothiazide Evolan

Keep out of sight and reach of children.

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

No special storage instructions.
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 hydrochlorothiazide , 12.5 mg or 25 mg per tablet.
  • The other ingredients are lactose monohydrate , colloidal anhydrous silica, corn starch and magnesium stearate.

What the medicine looks like and contents of the pack

12.5 mg: White, round tablet, diameter 6 mm.
25 mg: White, round tablet, diameter 8 mm.

All tablets have a break slot on one side, and can be divided into two equal parts.

Hydrochlorothiazide Evolan is available in pack sizes of 100 tablets and plastic cans of 100, 105, 250, 300, 400 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Evolan Pharma AB
Box 120
182 12 Danderyd
Email: info@evolan.se

Manufacturer

GL Pharma GmbH, Industriestra╬▓e 1, AT-8502 Austria

Muhammad Nadeem

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