Clinical Safety & Adverse Reactions

1.

Purpose

This policy explains how SynovaMed identifies, manages, and reports adverse drug reactions (ADRs) and patient safety concerns across every clinical service we offer including weight loss, hair loss, erectile dysfunction, women's health, skin, and sexual health.

2.

General Principles

Every medicine we prescribe has potential side effects. Most are mild and manageable, but some can be serious. Our approach is the same across every service:

• We provide clear information on common and serious side effects before you start.
• We check in with you after starting treatment.
• We encourage you to report any side effect - no matter how minor.
• Serious adverse drug reactions are reported to the MHRA within 15 days.
• Our prescribers adjust or stop treatment where side effects indicate harm.

3.

Red-Flag Symptoms – Seek Urgent Medical Help

Call 111, or 999 in an emergency, or go to A&E, if you experience any of the following while on any medication from SynovaMed:

• Signs of a severe allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing; widespread rash.
• Chest pain, sudden breathlessness, or signs of stroke (facial droop, arm weakness, slurred speech).
• Severe abdominal pain (especially persistent, radiating to the back).
• Sudden visual changes.
• Unusual bleeding or bruising.
• Yellowing of skin or eyes (jaundice).
• Signs of a blood clot (painful, swollen calf; breathlessness).
• Thoughts of harming yourself or others.
• Any sudden, severe, or unexpected change in how you feel.

4.

Service-Specific Safety Information

4.1 Weight Loss (GLP-1 receptor agonists)

Common side effects: Nausea, vomiting, diarrhoea, constipation, reduced appetite, indigestion, tiredness, injection-site reactions. Usually improve after 2-4 weeks or after dose steps.

Serious – seek urgent help:

• Severe upper abdominal pain radiating to the back (possible pancreatitis).
• Persistent vomiting with dehydration.
• Severe abdominal pain with fever or jaundice (possible gallbladder disease).
• Sudden vision changes (if you have diabetic retinopathy).
• Signs of hypoglycaemia if taking insulin/sulfonylurea.

Pregnancy: Not to be used in pregnancy. If you discover you're pregnant: stop immediately and contact us and your GP. Do not restart until ≥ 2 months after stopping breastfeeding.

4.2 Hair Loss (finasteride, minoxidil)

Finasteride common side effects: Reduced libido, erectile dysfunction, reduced ejaculate volume, breast tenderness.

Finasteride serious:

• Persistent sexual dysfunction after stopping (post-finasteride syndrome).
• Mood changes, depression, or suicidal thoughts.
• Breast lumps, pain, or discharge (rare risk of male breast cancer).
• Allergic reaction (rash, itching, swelling).

Minoxidil common: Scalp irritation (topical); low blood pressure, oedema, unwanted body hair (oral). Do not use if pregnant or breastfeeding.

Minoxidil serious: Palpitations, chest pain, significant fluid retention.

4.3 Erectile Dysfunction (PDE5 inhibitors)

Common: Headache, flushing, nasal congestion, indigestion, back pain.

Serious – seek urgent help:

• Priapism - painful erection lasting more than 4 hours – medical emergency.
• Chest pain, palpitations, fainting during or after sexual activity.
• Sudden hearing loss or tinnitus.
• Sudden vision loss in one or both eyes (possible NAION).
• Severe allergic reaction.

Never combine with nitrates or guanylate cyclase stimulators - life-threatening drop in blood pressure.

4.4 Women's Health – Contraception and HRT

Common (oestrogen-containing): Breakthrough bleeding, breast tenderness, nausea, mood changes, headache.

Serious – seek urgent help:

• Signs of a blood clot: painful or swollen calf, sudden breathlessness, chest pain.
• Severe headache, especially with neurological symptoms (visual change, speech change, weakness).
• Jaundice (yellowing of skin/eyes).
• New breast lump.
• Severe abdominal pain.

4.5 Women's Health – Acute Treatments (UTI, BV, thrush)

Common: GI upset, taste changes, headache.

Serious – seek urgent help:

• Severe allergic reaction.
• Severe or bloody diarrhoea (possible C. difficile).
• Worsening symptoms despite completing course.
• Fever, loin pain, blood in urine – possible upper UTI, possible pyelonephritis or resistance.

4.6 Skin (tretinoin, topical antibiotics, acne treatments)

Common: Redness, dryness, peeling, photosensitivity, mild irritation.

Serious:

• Severe allergic reaction.
• Severe skin reaction with blistering or widespread rash.
• Worsening acne after several weeks (signal for review).

Do not use in pregnancy. Use effective sun protection throughout treatment.

4.7 Sexual Health (antibiotics, antivirals)

Common: GI upset, nausea, tiredness, headache.

Serious:

• Severe allergic reaction (anaphylaxis).
• Severe or bloody diarrhoea.
• Liver-related symptoms: yellowing, dark urine, pale stools.
• Symptoms persisting or recurring after full course – needs re-consultation.

5.

MHRA Safety Signals

We monitor MHRA safety communications actively and update this policy when new signals emerge. Current notable signals include:

• GLP-1s: suicidal ideation reports under review; pancreatitis; thyroid C-cell tumours; gastroparesis; reduced efficacy of oral contraceptives (Mounjaro).
• Finasteride: persistent sexual dysfunction/mood changes (post-finasteride syndrome).
• Oral minoxidil: cardiovascular effects at higher doses.
• Combined hormonal contraception: VTE risk, stroke risk in migraine with aura.
• HRT: breast cancer and VTE risk profiles (ongoing review).

6.

Reporting Adverse Drug Reactions

If you experience a side effect, please report it to us so we can support you and report to the MHRA. You can:

• Email info@synovamed.co.uk or phone 07822 002914.
• Report directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk.
• Ask your GP or pharmacist to report on your behalf.

Serious ADRs are reported by our clinical team to the MHRA within 15 days. We keep an internal ADR register reviewed at every clinical governance meeting.

7.

Pregnancy & Breastfeeding

Many of the medicines we prescribe are not to be used in pregnancy or breastfeeding. If you discover you are pregnant while on any treatment from SynovaMed:

• Stop the medication and contact us immediately.
• Speak to your GP or midwife as soon as possible.
• Do not restart treatment without prescriber review.

8.

Interactions

Always tell us about:

• All prescription medication you take, including those from your GP or specialist.
• All over-the-counter medicines you regularly use.
• Herbal remedies, supplements, and vitamins.
• Recreational substances and alcohol (we treat this information confidentially).

9.

Storage and Use of Your Medicine

Follow the patient information leaflet (PIL) supplied with every medicine. In general:

• Refrigerate at 2-8°C if required (GLP-1 pens, some vaccines, insulin) – check the PIL.
• Keep oral medicines in their original packaging at room temperature unless told otherwise.
• Keep all medicines out of sight and reach of children.
• Do not use any medicine that looks damaged, discoloured, or past its expiry date.
• Return any unwanted medicines to a local pharmacy for safe disposal.

10.

Stopping Treatment

If you need to stop any treatment, speak to us first. Some medicines need tapering; some conditions rebound when treatment stops. We can support you with the right approach.

11.

Policy Review

Reviewed every 2 years, or sooner if new MHRA safety signals emerge. Next review: April 2028.

SynovaMed (trading name of Nihaal Limited) | 11 Blaby Road, South Wigston, Wigston, LE18 4PA | GPhC: 9012552 | 07822 002914 | info@synovamed.co.uk Document Ref: POL-008 | Version 2.0 Effective: 19 April 2026 | Next Review: April 2028 Superintendent Pharmacist: Chirag Desai (GPhC: 2079415)