Doxazosin 0.4 mg/ml Oral Suspension

• 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.
• Doxazosin 0.4 mg/ml oral suspension is a treatment for high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
• You should take Doxazosin 0.4 mg/ml oral suspension regularly to get the maximum benefit, even if you are feeling well.
• Most people do not have serious problems when taking Doxazosin 0.4 mg/ml Oral Suspension but side effects can occur. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines.
• If you are, or are trying to become, pregnant, do not take Doxazosin 0.4 mg/ml oral suspension and tell your doctor or pharmacist.

The name of your medicine is Doxazosin 0.4 mg/ml oral suspension but it will be referred to as ‘Doxazosin’ throughout this leaflet.

1. What Doxazosin is and what it is used for
2. What you need to know before you take Doxazosin
3. How to take Doxazosin
4. Possible side effects
5. How to store Doxazosin
6. Contents of the pack and other information

• You are allergic to doxazosin, other types of quinazolines (such as prazosin or terazosin), or any of the other ingredients of this medicine (listed in section 6). This may have been itching, reddening of the skin or difficulty in breathing.
• You are under 18 years of age.
• You have low blood pressure.
• You have a history of a condition known as ‘orthostatic hypotension’ which is a form of low blood pressure that causes you to feel dizzy or light-headed when you stand up from sitting or lying down.
• You have an enlarged prostate gland with one of the following: any kind of congestion or blockage in your urinary tract, a longstanding infection of the urinary tract or you have bladder stones.
• You have overflow incontinence (you do not feel the urge to urinate), or anuria (your body is not producing any urine) with or without kidney problems.

Talk to your doctor or pharmacist before taking Doxazosinn if:

• You are pregnant or trying to become pregnant
• You have liver disease
• You have heart disease
• You are also taking other medicines

If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Doxazosin. This is because Doxazosin may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Before starting treatment with Doxazosin your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia (enlargement of the prostate gland).

Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately.

When you start to take Doxazosin you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself. Your doctor may want to measure your blood pressure regularly at the start of therapy to reduce the possibility of these effects happening

Doxazosin is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established. Benign prostate hyperplasia is not relevant in children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

There are some medicines that may interact with Doxazosin. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of Doxazosin:

• Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking medicines called PDE-5 inhibitors for the treatment erectile dysfunction (impotence) with alpha-blockers e.g. sildenafil, tadalafil, vardenafil (please see Section “Warnings and precautions”). In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha blocker before you start drugs for erectile dysfunction.
• Doxazosin may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.
• Medicines to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Refer to section 3.

Pregnancy

The safety of using Doxazosin during pregnancy has not been established. If you are pregnant or trying to become pregnant speak to your doctor, who will decide if is suitable for you.

Breast-feeding

Small amounts of doxazosin, the active substance of Doxazosin, can get into your breast milk.

You should not use Doxazosin during breast-feeding unless your doctor advises you to do so.

Take care if you drive or operate machinery. Doxazosin may affect your ability to drive or operate machinery safely, particularly when you first start to take them. It may cause drowsiness, make you feel weak or dizzy. If you are affected, do not drive or operate machinery and contact your doctor immediately.

Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Propylene glycol (E1520): This medicine contains 4.75 mg propylene glycol in each 5 ml dose which is equivalent to 0.95 mg/ml.

Sodium: This medicine contains less than 1mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’

Benzoic acid: This medicinal product contains 0.055 mg benzoic acid in each 5 ml dose which is equivalent to 0.011 mg/ml.

• This medicine must be taken orally.
• Use the measuring syringe provided in the pack to deliver the required dose.
• Doses of 10 ml or below should be administered using the 10ml syringe. For doses greater than 10ml, the 20 ml syringe should be used.

Instructions for the use of syringe:

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of suspension by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient's mouth to avoid a choking hazard. Close the bottle with the plastic cap. Wash the syringe with water (figure 8).

Taking too much Doxazosin may make you unwell. If too much is taken it may be dangerous. Tell your doctor immediately or go to your nearest hospital casualty department.

If you forget to take a dose, leave that dose out completely. Then go on as before. Do not take a double dose to make up for a forgotten dose.

Do not suddenly stop taking your medicine as this may cause serious changes in your blood pressure.

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is doxazosin (as mesilate).

Each ml of oral suspension contains 0.4 mg doxazosin (as mesilate).

The other ingredients are:

methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate, (E216), simethicone emulsion 30% (contains benzoic acid (E210), low volatile simethicone intermediate, polyoxyethylene sorbitan tristearate, methylcellulose, poly (ethylene oxide), stearate, glyceryl stearate, xanthan gum, sorbic acid, sulfuric acid 98% & purified water), microcrystalline cellulose and carmellose sodium, glycerol (E422), sucralose (E955), citric acid anhydrous (E 330), lemon flavour (contains propylene glycol (E1520)) and purified water.

Doxazosin is a white to off white coloured suspension with lemon flavour supplied in amber glass bottles fitted with a tamper evident, child resistant white plastic (polyethylene/polypropylene) cap with EPE liner. The pack also contains 20 ml syringe with 0.5 ml graduation marks and 10 ml oral syringe with 0.25 ml graduation marks and a syringe adaptor.

Doxazosin is supplied in a bottle containing 150 ml oral suspension.