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identifier: id: 0d69fdcb-33cf-407f-8209-a6529856ab4f

status: FINAL

type: Package Leaflet (rmswi#100000155538)

date: 2022-02-16 13:28:17+0000

author: See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)

title: TEST PURPOSES ONLY - cava (irbesartan) 75 mg tablets

cava 75 mg tablets

irbesartan

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• What cava is and what it is used for
• What you need to know before you take cava
• How to take cava
• Possible side effects
• How to store cava
• Contents of the pack and other information

cava belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. cava prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. cava slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

cava is used in adult patients

• to treat high blood pressure (essential hypertension)
• to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

• if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also better to avoid cava in early pregnancy – see pregnancy section)
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Talk to your doctor before taking cava and if any of the following apply to you:

• if you get excessive vomiting or diarrhoea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you receive cava for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
• if you are going to have an operation (surgery) or be given anaesthetics
• • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
  • aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take cava”.

You must tell your doctor if you think you are (or might become) pregnant. cava is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

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

Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take cava” and “Warnings and precautions”).

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium
• repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

cava can be taken with or without food.

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking cava before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of cava. cava is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Tell your doctor if you are breast-feeding or about to start breast-feeding. cava is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

cava is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

cava is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take cava with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take cava until your doctor tells you otherwise.

• Patients with high blood pressure

  The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

• Patients with high blood pressure and type 2 diabetes with kidney disease

  In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

cava should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you accidentally take too many tablets, contact your doctor immediately.

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking cava and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with cava were:

• Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
• Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
• Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of cava. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

• The active substance is irbesartan. Each tablet of cava 75 mg contains 75 mg irbesartan.
• The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “cava contains lactose”.

cava 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

cava 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Acme inc

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

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Generated Narrative: ClinicalUseDefinition

Resource ClinicalUseDefinition "e60575aa-e7b3-4461-a456-d310514f4041"

Profile: ClinicalUseDefinition Interaction (ePI)

Texts

-	Div
*	<div></div>

identifier: id: YL5FZ2Y5U1 (use: OFFICIAL)

type: INTERACTION

subject: See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)

interaction

Interactants

-	Item[x]
*	METHOTREXATE (#YL5FZ2Y5U1)

21. urn:uuid:f7d8f2a0-27eb-4e37-8036-58f3d5aa6537 (ClinicalUseDefinition/f7d8f2a0-27eb-4e37-8036-58f3d5aa6537)

Generated Narrative: ClinicalUseDefinition

Resource ClinicalUseDefinition "f7d8f2a0-27eb-4e37-8036-58f3d5aa6537"

Profile: ClinicalUseDefinition Interaction (ePI)

Texts

-	Div
*	<div></div>

identifier: id: JQ9EK2H6BG (use: OFFICIAL)

type: INTERACTION

subject: See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)

interaction

Interactants

-	Item[x]
*	GRAPEFRUIT JUICE (#JQ9EK2H6BG)

22. urn:uuid:ac21a804-cafa-41ff-b644-a14c8003edeb (ClinicalUseDefinition/ac21a804-cafa-41ff-b644-a14c8003edeb)

Generated Narrative: ClinicalUseDefinition

Resource ClinicalUseDefinition "ac21a804-cafa-41ff-b644-a14c8003edeb"

Profile: ClinicalUseDefinition Warning (ePI)

Texts

-	Div
*	<div></div>

identifier: id: hypotension (use: OFFICIAL)

type: WARNING

subject: See above (MedicinalProductDefinition/800a51a2-d81d-49a4-a4eb-f2417d301837)

Warnings

-	Description
*	Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of cava.

23. urn:uuid:da33bd51-a726-4232-aaa0-4168b9bfe249 (SubstanceDefinition/da33bd51-a726-4232-aaa0-4168b9bfe249)

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "da33bd51-a726-4232-aaa0-4168b9bfe249"

Profile: SubstanceDefinition (ePI)

Texts

-	Div
*	<div></div>

identifier: id: J0E2756Z7N (use: OFFICIAL)

version: 1

status: Validated (UNII) (#1)

description: White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 1234 engraved on the other side.

manufacturer: See above (Organization/d71bf884-90eb-47f9-81b7-fa81ecec7e75)

MolecularWeights

-	Type	Amount
*	exact ()	428.53

Structures

-	MolecularFormula
*	C25H28N6O

Names

-	Name	Type
*	(+)-6-methyleneandrosta-1,4-diene-3,17-dione	Chemical Name (#1)