25 mg tablets
hydrochlorothiazide

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

Hydrochlorothiazide Orifarm is a diuretic and antihypertensive drug. The decrease in blood pressure is partly due to the diuretic effect but probably also to the fact that certain blood vessels ( arterioles ) dilate and thus lower the resistance in the blood vessels.

Hydrochlorothiazide Orifarm is used for:

  • high blood pressure
  • fluid retention in the body ( edema )
  • in Ménière’s disease (disease of the inner ear).

Hydrochlorothiazide contained in Hydrochlorothiazide Orifarm 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 use Hydrochlorothiazide Orifarm

Do not take Hydrochlorothiazide Orifarm

  • if you are allergic to hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
  • if you are hypersensitive to certain other diuretics ( diuretics ).
  • if you are hypersensitive to certain antibiotics ( sulfonamides ).
  • if you have severe liver disease.
  • if you have severe kidney disease with low urine production.
  • if you have gout .

Warnings and cautions

Talk to your doctor or pharmacist before taking Hydrochlorothiazide Orifarm:

  • If you have diabetes .
  • If you have atherosclerosis in your heart or brain.
  • If you have a disturbed salt or electrolyte balance in your blood ( potassium , magnesium , sodium , calcium or uric acid ), your doctor may want to monitor you more closely.
  • If you experience impaired vision or eye pain. This may be a symptom offluid retention in the eye (between the choroid and retina) or an increase in pressure in the eye and may occur within hours to weeks after taking Hydrochlorothiazide Orifarm. This can lead to permanent visual impairment if left untreated. If you have previously had a penicillin or sulfonamide allergy, you may be at higher risk of developing this.
  • If you have asthma or allergic symptoms.
  • 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 Orifarm.

For long-term treatment with Hydrochlorothiazide Orifarm, the diet must contain enough potassium. This is especially important if you may lose extra potassium, e.g. if you have severe vomiting or diarrhea.

Other medicines and Hydrochlorothiazide Orifarm

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

  • The treatment effect may be affected if Hydrochlorothiazide Orifarm is taken at the same time as certain other medicines. This is especially important for the following:
  • Digitalis glycosides and sotalol, which are drugs that affect the heart rhythm.
  • Non-steroidal anti-inflammatory / anti-rheumatic drugs ( NSAIDs ) used in the treatment of pain.
  • Cholestyramine and colestipol used in the treatment of high blood fats.
  • Lithium, antidepressants, antipsychotics used in the treatment of mental disorders.
  • Carbamazepine used to treat epilepsy and certain mental disorders.
  • Selective serotonin reuptake inhibitors ( SSRIs ) used to treat depression.
  • Other antihypertensive drugs.
  • Insulin and other medicines for diabetes .
  • Carbenoxolone used for ulcers or inflammation of the esophagus.
  • Adrenocorticotropic hormone is used to treat adrenal insufficiency.
  • Glucocorticoid is.
  • Medicines for the treatment of irregular heartbeat.
  • Anticholinergic drugs (drugs used to treat various diseases such as stomach cramps, bladder spasm , asthma , motion sickness, muscle cramps, Parkinson’s disease and as an aid to anesthesia).
  • Some medicines used to treat infection include amphotericin, penicillin G.
  • Alcohol, sleeping pills.
  • Drugs that increase blood pressure (pressoramines eg adrenaline , norepinephrine ).
  • Muscle relaxants used during surgery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Tell your doctor if you are breastfeeding or planning to start breastfeeding. Hydrochlorothiazide Orifarm is not recommended during breastfeeding.

Driving and using machines

The ability to drive or use machines may be impaired in some patients during treatment with Hydrochlorothiazide Orifarm. This is especially true at the beginning of treatment.

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

Hydrochlorothiazide Orifarm contains lactose monohydrate

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

3. How to use Hydrochlorothiazide Orifarm

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

The recommended dose is:

High blood pressure

Treatment is started with ½ – 2 tablets per day. The lowest possible dose should be used for continued treatment.

Edema

Treatment is started with 1-2 tablets per day. After starting treatment, it may be possible to continue treatment every two to three days.

Ménières disease

The treatment begins with 2 – 4 tablets per day divided into two doses during the first 4-6 weeks. Then dose one is reduced and can be stopped after a few months.

Dose one has taken preferably in the morning, (single dose) or in two divided doses you, morning and evening. The increased urine excretion begins about 2 hours after ingestion, is greatest after about 4 hours, and lasts up to 12 hours.

The tablet can be divided into two equal doses.

If you take more Hydrochlorothiazide Orifarm than you should

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

The symptoms of an overdose are fluid and electrolyte disturbances, thirst, dehydration, and disturbances in the pH value of the blood.

If you forget to take Hydrochlorothiazide Orifarm

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects are (may affect up to 1 in 10):

  • High blood sugar (with symptoms such as thirst, increased urination, dry mouth , blurred vision).
  • Weakness, dizziness, tiredness, headache.

Less common side effects are (may affect up to 1 in 100):

  • Fainting due to low blood pressure when you get up fast, irregular heartbeat.
  • Decreased appetite, nausea, vomiting, colic , diarrhea, constipation.
  • Skin rash, hives , increased sensitivity to sunlight.

Rare side effects are (may affect up to 1 in 1000 people):

  • Disorders of the blood, which can lead to anemia or loss of white blood cells.
  • Tingling in the arms or feet ( paresthesia ), sleep disorders, depression.
  • Dimsyn.
  • Breathing difficulties, pneumonia , water in the lungs.
  • Inflammation of the liver, blocked outflow of bile, inflammation of the pancreas.
  • Inflammation of the blood vessels, redness of the skin, toxic epidermal necrolysis , which is a potentially serious skin condition with blistering and flaking of the skin.
  • Kidney failure , kidney disease (interstitial nephritis).
  • Severe hypersensitivity reaction , fever, impotence .

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 ).


Laboratory test

Side effects that affect the blood have been reported. They will only be detected by laboratory tests.

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

Low level of potassium in the blood, elevated uric acid in the blood, increased level of fat ( cholesterol ).

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

Low level of magnesium or sodium in the blood, high level of potassium in the blood, high pH value in the blood due to low level of chloride, low level of phosphate in the blood.

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hydrochlorothiazide Orifarm

Keep this medicine out of the sight and reach of children.

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

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 25 mg.
  • The other ingredients are: Lactose monohydrate , powdered cellulose, crospovidone;povidone K 25; croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

What the medicine looks like and contents of the pack

Hydrochlorothiazide Orifarm is a white, round tablet with a scoreline on one side with a diameter of 8.9 to 9.2 mm and a height of 2.4 to 3.2 mm.

PVC / PVDC / Alu blister with: 28, 30, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm

info@orifarm.com

This medicinal product is authorized under the European Economic Area under the names:

Norway: Hydrochlorothiazide Orifarm

Denmark: Hydrochlorothiazide Orifarm

Sweden: Hydrochlorothiazide Orifarm

Muhammad Nadeem

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