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PINEXEL PR 400 MICROGRAMS PROLONGED-RELEASE HARD CAPSULES
Active substance(s): TAMSULOSIN HYDROCHLORIDE / TAMSULOSIN HYDROCHLORIDE / TAMSULOSIN HYDROCHLORIDE
Neutral code not required on the leaflet artworks.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pinexel PR 400 micrograms
Prolonged-Release Hard Capsules
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again while you are receiving your treatment.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
- If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
The name of your medicine is Pinexel PR 400 micrograms Prolonged-Release Hard Capsules. In the
rest of this leaflet it is called Pinexel PR Capsules.
In this leaflet:
1. What Pinexel PR Capsules are and what they are used for
2. Before you take Pinexel PR Capsules
3. How to take Pinexel PR Capsules
4. Possible side effects
5. How to store Pinexel PR Capsules
6. Further information
1. WHAT PINEXEL PR CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance in Pinexel PR Capsules is tamsulosin (as hydrochloride), which belongs to a
group of medicines called alpha-blockers (alpha-adrenoreceptor antagonists).
Tamsulosin is used for the treatment of urination symptoms caused by benign prostatic hyperplasia
BPH means that the prostate gland enlarges (hypertrophy) but the
growth is not cancerous (it is benign).
The prostate gland is just underneath the bladder. The urethra (the
tube through which urine passes from the bladder to the outside of the
body) runs through the prostate gland. If the prostate enlarges, it
presses on the urethra, causing it to narrow. This makes it difficult to
Pinexel PR Capsules relax the muscle of the prostate gland widening
the urethra and so ease the passing of urine.
2. BEFORE YOU TAKE PINEXEL PR CAPSULES
Do not take Pinexel PR Capsules if:
• you are allergic to tamsulosin hydrochloride, or any of the other ingredients of Pinexel PR Capsules
(see list under ‘What Pinexel PR Capsules contain’ in section 6). Hypersensitivity can express itself
as sudden swelling of face, hands and feet, difficulties in breathing and/or itch and rash
• you have experienced dizziness or have fainted due to an abnormal decrease in blood pressure
when standing up (orthostatic hypotension)
• you suffer from severe liver problems.
Talk to your doctor before taking this product if any of the above applies to you.
Take special care with Pinexel PR Capsules if:
• you suffer from severe kidney problems
• you are due to have surgery to remove a cataract.
Do not give this medicine to children or adolescent under
18 years because it does not work in this population.
If any of the above apply to you, it is important that you tell your doctor or pharmacist before taking
Pinexel PR Capsules and they will decide what to do.
STOP TAKING PINEXEL PR CAPSULES AND CONTACT YOUR DOCTOR OR PHARMACIST
• you experience dizziness or fainting during the use of Pinexel PR Capsules. Please sit or lie down
straight away until the symptoms disappear
• you experience sudden swelling of face, hands or feet, difficulties in breathing and/or itch and rash,
caused by an allergic reaction (angio-oedema) whilst taking Pinexel PR Capsules.
Taking other medicines
Taking other medicines when taking Pinexel PR Capsules can affect how it or the other medicine
works. Make sure that your doctor knows what other medicines you are taking.
Do not take any other medicines while you are taking Pinexel PR Capsules unless you have told your
doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself
without a prescription.
Please check with your doctor if you are taking any of the following (or any other medication):
• Any medicines which are used to reduce inflammation in the body (anti-inflammatory medicines
• Any medicines used to prevent the clotting of blood (anticoagulants e.g. warfarin).
• Other medicines used to reduce blood pressure, including anaesthetics and other alpha-blocker
(alpha-adrenoceptor antagonists, e.g. doxazosin, prazosin and indoramin).
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 drugs for erectile dysfunction (impotence) with alpha-blockers. 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.
If you have any doubts about whether you should be given this medicine, then talk to your doctor.
Pregnancy and breast-feeding
Not applicable as Pinexel PR Capsules are intended for male patients only.
Driving and using machines
Pinexel PR Capsules may cause drowsiness, blurred vision and dizziness. If you are affected you
should not drive or operate machinery.
3. HOW TO TAKE PINEXEL PR CAPSULES
Always take Pinexel PR Capsules exactly as your doctor has instructed you to. You should check with
your doctor or pharmacist if you are not sure.
ART WORK CHECK BOX
PLANT LOCATION :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
RECEIVED ON :
PROOF REVISION :
Tamsulosin Hcl 400mcg - 30 Capsules
(w)148 x (h)420mm
Adobe Illustrator CS5
Helvetica Medium Condensed / Bold Condensed
21st & 29th October, 2014
R 1st PDF sent on - 29TH OCT. 2014
R 2nd PDF sent on - 25TH JUNE 2015
CHANGE CONTROL : Version changes due to change in:
Changes in detail: • Regulatory text amends • Text font size increased to 9pt.
• Dimensions changed to 148mm x 420mm
in order to accomodate bigger text font size
• Pharmacode re-positioned on 6th fold
and placed on 8mm from the cutting edge
• Layout style changed to single column
How to take your medicine
The usual dose is one capsule a day after the first meal of the day. The capsule should be taken while
standing or sitting upright (not lying down) and should be swallowed whole with a glass of water.
Taking Pinexel PR Capsules with food and drink
Pinexel PR Capsules should be taken after the same meal each day. Taking Pinexel PR Capsules on an
empty stomach may increase the risk of side effects.
Pinexel PR is a specially designed capsule from which the active ingredient is gradually released. Do
not crush or chew the capsule as this will interfere with how the medicine works.
If you take more Pinexel PR Capsules than you should
Your doctor will decide the dose that is best for you. If you think you have taken too many capsules,
contact your doctor, nurse, pharmacist or nearest hospital immediately.
Signs that you or someone else has taken too many Pinexel PR Capsules include fainting, dizziness,
light-headedness, palpitations, blurred vision and confusion, vomiting and diarrhoea.
If you forget to take Pinexel PR Capsules
If you forget to take a dose of Pinexel PR Capsules, wait until your next dose is due and take this as
normal. Do not take a double dose to make up for a forgotten capsule.
4. POSSIBLE SIDE EFFECTS
Like many medicines, Pinexel PR Capsules may cause side effects in some patients, although not
everybody gets them. You should inform your doctor or nurse immediately if you feel unwell.
Common (less than 1 in 10 but more than 1 in 100 patients)
Uncommon (less than 1 in 100 but more than 1 in 1,000 patients)
• headache, a lack of strength or energy
• a fall in blood pressure (often when you stand up resulting in light-headedness), palpitations
• rhinitis (sneezing, blocked or stuffy nose, runny nose, itchy nose,
throat and eyes)
• nausea, vomiting, diarrhoea and constipation
• rash; itchy skin; raised, itchy skin (known as hives)
• abnormal ejaculation (i.e. less, or no noticeable, semen ejaculated).
Rare (less than 1 in 1,000 patients)
• angio-oedema (severe swelling of the skin, particularly of the face,
hand, feet or voicebox, difficulties in breathing and/or itch and rash)
• temporary loss of consciousness.
Very rare (less than 1 in 10,000 patients)
• priapism (a painful prolonged erection).
Frequency not known
• dry mouth
In some occasions possible complications in connection to cataract operations have been observed.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
systems listed below:
United Kingdom: Yellow Card Scheme
Malta: ADR Reporting, Website:www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PINEXEL PR CAPSULES
Keep this medicine out of the reach and sight of children.
• This medicine should not be used after the expiry date shown on the carton and blister. The expiry
date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
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.
What Pinexel PR Capsules look like and contents of the pack
Pinexel PR Capsules consist of a light green opaque cap printed with W
516 and light yellow opaque body
containing white to off white pellets. The capsules are contained in a blister pack in a cardboard box.
They are available in packs of 30 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Pinexel PR 400 micrograms Prolonged-Release Hard Capsules
Ireland: Kirnom XL 400 micrograms Prolonged-Release Hard Capsules
Cyprus: Pinexel PR 400 micrograms Prolonged-Release Hard Capsules
Malta: Pinexel PR 400 micrograms Prolonged-Release Hard Capsules
Germany: Pinexel PR 400 mikrogramm Hartkapseln, retardiert
Poland: Pinexel PR
Pinexel PR 400 micrograms Prolonged-Release Hard Capsules
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:
The other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1)
dispersion 30 per cent, talc, purified water, magnesium stearate and triethyl citrate. The outer shell of
the capsule contains hard gelatin, sodium laurilsulfate, quinoline yellow (E104), titanium dioxide
(E171), brilliant blue (E133), shellac and black iron oxide (E172).
What Pinexel PR Capsules contain
Pinexel PR Capsules contain the active ingredient tamsulosin hydrochloride. Each capsule contains
400 micrograms of tamsulosin hydrochloride (equivalent to 367 micrograms tamsulosin).
6. FURTHER INFORMATION
Leaflet prepared: 06/2015
This is a service provided by the Royal National Institute of Blind People.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.